Authority paper by 3gz600u

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									                                                                       HFEA (17/10/07) 401




Multiple births and single embryo transfer review:
evidence base and policy analysis
 Committee:               Authority Meeting

 Meeting Date:            17 October 2007

 Agenda Item:             7

 Paper Number:            HFEA (17/10/07) 401

 Paper Title:             Multiple births and single embryo transfer review: evidence base
                          and policy analysis

 Authors:                 Juliet Tizzard, Deputy Head of Policy
                          Melissa Cummins, Policy Officer (Annex A)
                          Stephanie Croker, Policy Officer (Annex B)
                          Additional research and statistical analysis by Stephanie Croker,
                          Melissa Cummins and Antony Blackburn-Starza

 For Information or       Decision
 Decision?

 Resource Implications:   Significant staff and other resources already spent. Resources for
                          implementation and evaluation set aside for 2007-8 and 2008-9
                          business years.

 Implementation:          Implementation considerations built into policy options.
                          Implementation phase planned for November 2007-July 2008,
                          depending upon the options chosen, in conjunction with Regulation
                          and Communications departments.

 Communication:           Decision to be communicated immediately after the November
                          Authority decision. Communications plan for implementation phase
                          in place, pending Authority decision.

 Organisational Risk:     High

 Recommendation to the    To agree a policy which will reduce the incidence of multiple births
 Committee:               following IVF without significantly reducing success rates or
                          increasing costs to patients.

 Evaluation:              Ongoing monitoring of the policy decision incorporated into 2008-9
                          business plan. Evaluation to follow in 2009-10 business year.




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Section A: Overview
1    Introduction

1.1 The Multiple births and single embryo transfer review launched in August 2005.
    The aim of the review was to work closely with a range of patient and
    professional stakeholders and experts to assess whether and under what
    conditions single embryo transfer would be a viable option for reducing the twin
    birth rate in the UK, without significantly impairing live birth rates.

1.2 The first phase of the review started with the formation of an Expert Group,
    chaired by Professor Peter Braude of the Royal College of Obstetricians and
    Gynaecologists. The Expert Group reviewed the literature on multiple births and
    single embryo transfer and considered the experience of countries which have
    introduced single embryo transfer.

1.3 In October 2006, the group published a set of recommendations aimed both at
    the HFEA and other stakeholders such as the Department of Health, Primary
    Care Trusts, professional bodies and patient groups. The group concluded that
    the risks associated with multiple births are significant and that steps should be
    taken to reduce the incidence of multiple births following IVF in order to
    minimise these risks to women and their babies. It also concluded that single
    embryo transfer for selected patients would be a feasible way of doing this.

1.4 Using the recommendations from the Expert Group as a guide, the HFEA
    launched a public consultation in April 2007 which sought views on four main
    options for HFEA policy in this area. This paper presents the findings of the
    consultation, which ran until July 2007, and provides the evidence which has
    been collected about the acceptability and feasibility of introducing single
    embryo transfer for selected patients in the UK.

2    Structure of the paper

2.1 Section B (page 4) of this paper discusses the UK fertility sector. It describes
    UK guidance on embryo transfer and gives an overview of clinical practice,
    including multiple birth rates, the use of single embryo transfer and blastocyst
    transfer, and how UK practice compares to that of a few other countries. It also
    discusses NHS funding for IVF and the presentation of outcome data by the
    HFEA.

2.2 Section C (page 13) provides a summary of the findings from the multiple births
    consultation, based upon views gathered through the written consultation, two
    consultation meetings and three patient focus groups. It gives an overview of
    stakeholder views organised around particular themes and shows responses to
    the policy options presented.

2.3 Section D (page 24) of this paper provides an analysis of the four policy options
    put out to public consultation and the additional option added by Regulation
    Committee. It considers the policy objectives set by the Expert Group,
    principles of better regulation and policy-making in relation to risk. The section
    then goes on to examine each of the five policy options in detail, considering:


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          feasibility: will it reduce the incidence of multiple births?;
          acceptability to stakeholders;
          how practical it is from a regulatory point of view;
          what the impact might be on patients’ experience of treatment; and
          what the regulatory burden on clinics is likely to be.

2.4 Section E, from page 44 onwards, contains the Annexes:

          Annex A: Evidence from the written consultation
          Annex B: Evidence from the practitioner consultation meeting
          Annex C: Evidence from the patient consultation meeting
          Annex D: Evidence from the patient focus groups
          Annex E: Current HFEA guidance
          Annex F: Consensus statement on multiple births in the UK

3    Questions for the committee

3.1 The Authority is asked to consider the following questions:

     a.    Are Members content that they have sufficient evidence – both about the
           scientific and clinical context and about stakeholders views – to make an
           informed decision?

     b.    What are Members’ thoughts about the appropriate level of HFEA
           intervention, bearing in mind the risks of multiple births (as discussed in
           the ‘Proportionality and risk’ section from page 24)? Should the HFEA’s
           goal be to minimise public health harms (i.e. the total impact of multiple
           births following IVF) or to minimise harms to individual patients and their
           children?

     c.    Are Members content that they have the appropriate policy options from
           which to make a choice?

     d.    Does the Authority accept Regulation Committee’s recommendation that
           Option 1 should be adopted as a bare minimum, regardless of any
           additional options which may be adopted?

     e.    If the Authority accepts the recommendation to adopt Option 1 as a
           minimum, does the Authority wish to adopt an additional policy? If yes, do
           Members have a preliminary view about their preferred policy? What is
           the rationale for this initial preference?

3.2 A final policy decision will be made at the November Authority meeting.




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Section B: The UK context
1     Introduction

1.1 The principal recommendation from the Expert Group on multiple births was
    that single embryo transfer (SET) is a feasible way of reducing the incidence of
    multiple births following IVF, based upon data published in countries where
    SET has been introduced. However, the group recognised that some of the
    factors present in the UK fertility sector create obstacles to the introduction of
    SET in the UK. This section gives information on the UK fertility sector so that
    the Authority is aware of the context in which it will make its policy.

2     Current HFEA guidance on embryo transfer

2.1 Since the first HFEA Code of Practice was published in 1991, centres have
    been expected to transfer no more than three embryos in an IVF cycle. In 2001,
    with the incidence of multiple births still relatively high, the HFEA introduced a
    two-embryo policy for women under 40 years. This policy expected centres to
    transfer a maximum of two embryos, except in exceptional circumstances,
    when three embryos could be transferred. In March 2004, when the Authority
    published the sixth edition of the Code of Practice, the policy was revised
    further, so that a maximum of two embryos can now be transferred to women
    under the age of 40, with no exceptions, and a maximum of three can be
    transferred to women aged 40 and over.

2.2 The current guidance in the 7th Code of Practice, unchanged from the 6th (in
    full at Annex E), expects centres to:

            transfer no more than two embryos to women under the age of 40 and no
             more than three embryos to women aged 40 or over1, or in the case of
             egg donation, transfer no more than two embryos to any woman;
            provide patients with information about the risks of multiple pregnancy and
             birth to the woman, fetus and any resulting child2;
            obtain the patient’s consent about how many embryos are to be
             transferred and to record the decision in the patient’s notes.

3     Other UK guidance and policy statements

3.1 In February 2004, the National Institute of Clinical Excellence (NICE) published
    a clinical guideline on fertility treatment3, superseding guidelines published by
    the Royal College of Obstetricians and Gynaecologists. The most notable part
    of the guideline is that eligible couples (23-39 years of age, with an identified
    cause of infertility or a duration of infertility of at least three years) should be


1
  Guidance 8.5.1 Risks: number of eggs or embryos to transfer
2
  Guidance 5.3.2 Information provision: multiple pregnancy
3
  Fertility: assessment and treatment for people with fertility problems National Institute for Clinical
Excellence, Clinical guideline 11, February 2004




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        offered up to three stimulated cycles of IVF. The guideline also recommends
        the following in relation to multiple births:

               ‘Couples should be informed that the chance of multiple pregnancy
               following in vitro fertilisation treatment depends on the number of embryos
               transferred per cycle of treatment. To balance the chance of a live birth
               and the risk of multiple pregnancy and its consequences, no more than
               two embryos should be transferred during any one cycle of in vitro
               fertilisation treatment.’

3.2 More recently, a number of professional and patient organisations came
    together to produce a consensus statement on multiple births and embryo
    transfer4. The statement said that ‘the goal of all fertility treatments should be
    the delivery of a single, healthy child, born at full term’ and that the high rate of
    multiple pregnancy was no longer tolerable. The statement made a number of
    recommendations, including:

              In good prognosis patients, SET should be offered routinely
              Commissioners must, as a minimum in the first instance, acknowledge the
               need to fund a single cycle of IVF (fresh plus thawed embryo transfers)
              Department of Health must encourage commissioners to consider full
               implementation of the NICE guideline
              HFEA should report clinic data in a way which encourages good practice
               in embryo transfer (i.e. cumulative rates per cycle started).

3.3 No specific recommendations on HFEA policy were made. However, it was
    suggested ‘a degree of proscription’ would be needed to bring about change.
    The statement is attached at Annex F.

4       Current UK practice and outcomes

Incidence of multiple births in the UK
4.1 In 2004, 22.8% of IVF live births involved the delivery of two or more babies.
     This compares with a multiple birth rate following all conceptions of roughly
     1.5% (10,548 of 709,239 deliveries). However, because the actual number of
     babies born following IVF is much lower than the number born following
     spontaneous conception, the overall contribution of IVF multiple births to all
     multiple births is relatively small. As an illustration, there were 10,548 multiple
     births in 2004, of which 1879 (17.8%) were IVF multiple births. However, all IVF
     deliveries make up 1.2% of all deliveries in the UK. IVF, therefore, makes a
     greater contribution, proportionally, to all multiple births than it does to all births.

4.2 It is often thought that intrauterine insemination (IUI), gamete intrafallopian
    transfer (GIFT) and ovarian stimulation are significant contributors to multiple
    births in the UK. No national data are collected on the number and outcomes of
    these procedures in the UK (although data on GIFT will be presented to


4
    ‘Multiple births in the UK: a consensus statement’ Hamilton M Human Fertility (2007) 10:2




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          Authority in November). However, a recent study which collected information
          about deliveries during one week in 2003, showed that IVF is a much more
          significant contributor to all multiple births than other forms of assisted
          conception5. Based upon 6913 deliveries at 178 UK maternity units (72.7% of
          all units), the study showed that 81% of twins were spontaneously conceived,
          13% were conceived following IVF, 5% following IUI, GIFT or ovarian
          stimulation and 1% were of unknown origin.

4.3 Data from ESHRE on IUI with partner gamete cycles performed during 2003 in
    18 European countries (UK not included) show a multiple birth rate of 11%6.

4.4 Since the implementation of the European Union Tissues and Cells Directive in
    July 2007, clinics performing IUI and GIFT with partner sperm have been
    required to report outcomes to the HFEA on an annual basis. This data, the first
    set of which will be collected in July 2008, will include information about
    multiple births and patient age, although the level of detail will be significantly
    lower than that of the IVF data collected on a cycle-by-cycle basis through
    Electronic Data Interchange.

Multiple births following IVF in the UK
4.5 The graph below charts the proportion of singleton, twin and triplet births and
     the proportion of single, double and triple embryo transfers over the years since
     1991. It shows that, as double embryo transfers have taken over prominence
     from triple embryo transfers, the proportion of triplet births has fallen from 3.5%
     in 1991 to 0.3% in 2006. A combination of the HFEA two-embryo policy and
     professional good practice (which was already resulting in fewer triple embryo
     transfers before 2004) has led to a situation today in which triplets are rare.

    90%


    80%

    70%

    60%
                                                                                                 Singleton Proportion
                                                                                                 Twin Proportion
    50%
                                                                                                 Triplet Proportion
                                                                                                 SET (% of transfers)
    40%
                                                                                                 DET (% of transfers)

    30%                                                                                          TET (% of transfers)


    20%

    10%

    0%
          1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006




5
  Modes of conception and multiple pregnancy: a national survey of babies born during one week in
2003 in the United Kingdom’ Bardis N et al Fertility and Sterility (2005) Vol. 84, no. 6
6
  Nyboe Anderson A et al Human Reproduction (2007)




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4.6 However, whilst the proportion of triplet births has fallen considerably since
    1991, the proportion of twin births has fallen only slightly: from 25.1% in 1991 to
    22.3% in 2006. In 2006, the proportion varies from 0 to 44.4% across all 72 IVF
    clinics. However, when clinics performing 100 or fewer cycles per year are
    excluded, the proportion of twin births varies from 6.7% and 37.1% across 68
    clinics. The vast majority of twins are born following two embryo transfer to
    women under 40 years. A very small proportion of these are likely to be
    identical twins conceived from one of the two embryos transferred, though it is
    not possible from the HFEA data to separate these from the non-identical twins.

Single embryo transfer in the UK
4.7 The transfer of one embryo during IVF has traditionally been carried out only
     where there was only one embryo available for transfer. These cycles make up
     about 10% of all IVF cycles. Since the move in some countries to elective
     single embryo transfer (eSET), where two or more good quality embryos are
     available for transfer, there was been discussion within the UK fertility sector
     about the possibility of moving in the same direction. However, this growing
     interest in eSET has not translated into an increased uptake of the practice.

4.8 The HFEA does not currently collect information about eSET, though it will start
    to do so from October 2007. However, by looking at those single embryo
    transfer cycles in which surplus embryos have been transferred to frozen
    storage, it is possible to estimate which SET cycles are elective7.

4.9 The table below shows non-elective and elective single embryo transfer cycles
    as a proportion of all embryo transfer cycles in 2004, 2005 and 2006. The
    proportion of non-elective SET cycles has remained constant over the years at
    between 9 and 10%, whilst the proportion of elective SET cycles tripled
    between 2004 and 2006.

            All cycles   Non-SET     % non-       Non-          % non-        Elective       % eSETs
                         cycles      SET          elective      eSET          SET            of all
                                     cycles of    SET           cycles of     cycles         cycles
                                     all cycles   cycles        all cycles
    2004    27668        25134       90.8%        2363          8.6%          171            0.6%
    2005    27949        25234       90.3%        2494          8.9%          221            0.8%
    2006*   29224        25802       88.3%        2760          9.4%          662            2.3%
Table: Non-single embryo transfers, non-elective single embryo transfers and elective single embryo
transfers and proportions of all embryo transfers. *The number of live births in 2006, and therefore the
live birth rate, will increase because not all outcomes have yet been reported.

4.10 However, the number of eSET cycles is still very low: less than 3% of all
     embryo transfers in 2006. Further, the high rate of growth from 2005 to 2006 is
     not due to an increase in cleavage stage embryo (day 2 to 3) transfers, but in

7
 The Register definition of an elective single embryo transfer is one where three or more embryos
were created, one transferred to the patient and one or more embryos frozen for the patient’s future
use. This is a cautious definition, so the data at the Table may under-estimate the number of eSETs.




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        blastocyst stage (day 5 to 6) transfers. Of the 662 eSETs in 2006, 350 (52.9%)
        were elective blastocyst transfers (see below for further data and discussion on
        blastocyst transfer), leaving 312 eSETs, a 67% increase from 2005.

4.11 What are the pregnancy and live birth rates following elective single embryo
     transfer? The table below compares eSET cycles with all embryo transfer
     cycles, taking into consideration the pregnancy rate and the live birth rate,
     broken down by age group. These rates following eSET are comparable with
     those following all embryo transfer cycles. However, the total number of eSET
     cycles is too low to be able to reliably measure the impact of eSET.

                             eSET         eSET     eSET live        All ET      All ETs       All ETs
                            cycles    preg. rate   birth rate       cycles    preg. rate    live birth
                                                                                                  rate
 2004      Up to 35             84        23.8%        23.8%        12392         35.0%        31.9%
           35-39                59        27.1%        23.7%        10685         26.9%        23.4%
           40+                   5        40.0%        20.0%          4591        17.8%        14.0%
           Total               148        25.7%        23.6%        27668         29.0%        25.7%
 2005      Up to 35             85        27.1%        22.4%        12160         37.2%        30.6%
           35-39                89        25.8%        18.0%        11031         28.6%        22.6%
           40+                  13        15.4%         7.7%          4758        16.6%        12.8%
           Total               187        25.7%        19.3%        27949         30.3%        24.4%
 2006*     Up to 35            173        35.3%                     12178         38.6%
           35-39               126        23.8%                     11971         30.0%
           40+                  13        23.1%                       5075        18.3%
           Total               312        30.1%                     29224         31.5%
Table: Pregnancy rates and live birth rates following single embryo transfer compared with all embryo
transfers, by year and age of patient. *The number of live births in 2006, and therefore the live birth
rate, will increase because not all outcomes have yet been reported.

Blastocyst transfer
4.12 Over the past few years, IVF practitioners have started to culture embryos
     longer in the laboratory in order to see how they develop before transfer.
     Although there is still some debate about the merits of extended culture, the
     technique does seem to be associated with higher pregnancy and live birth
     rates than those of cleavage stage embryo transfer. However, this increased
     live birth rate is associated with a higher multiple birth rate when two embryos
     are transferred.

4.13 Data from the HFEA Register shows that there has been a substantial increase
     in the number of blastocyst transfer cycles, with an increase of 78.3% in the
     number of blastocyst transfer cycles between 2004 and 2006, increasing from
     1182 to 2108 blastocyst transfer cycles. Of the 75 licensed centres, 62.7%
     have performed blastocyst transfers to some degree over this time, with about
     20 centres (26.6%) performing blastocyst transfers on a consistent basis.




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4.14 Looking at all cycles in 2004, 2005 and 2006 together (4811 cycles), the data
     indicates that all blastocyst transfers (regardless of the number of blastocysts
     transferred) result in a higher live birth rate than all embryo transfers (blastocyst
     and cleavage stage transfers together), particularly in women under 35 years.
     However, the multiple birth rate for blastocyst transfers is significantly higher
     than that of all embryo transfer cycles.

                  Blastocyst         Blastocyst       Blastocyst        Embryo live              Embryo
                      cycles      live birth rate   multiple birth        birth rate        multiple birth
                                                              rate                                    rate
    Up to 35             2114             36.0%              38.3%             26.8%               27.9%
    35-39                1962             30.3%              26.9%             19.6%               20.0%
    40+                   735             19.7%              29.7%             11.5%               17.1%
Table: Blastocyst transfer live birth rates and multiple birth rates, compared with all embryo transfers.
The number of live births in 2006, and therefore the live birth rate, will increase because not all
outcomes have yet been reported.

4.15 Looking at the data according to the number of blastocysts transferred, it can
     be seen that double blastocyst transfers are largely responsible for the high
     proportion of multiple births following blastocyst transfers. The table below,
     which contains outcomes for elective single blastocyst transfer8 and double
     blastocyst transfer, shows that the transfer of a single blastocyst, particularly to
     women under 35 years, can result in comparable live birth rates to double
     blastocyst transfer, without the high incidence of multiple births. (The proportion
     of multiple births following elective single blastocyst transfer should be treated
     with caution as the total births are very low in number. For instance, there were
     only 12 births (of which 1 was a twin birth) to women over 40 having eSBT.)

               eSBT as %        eSBT live           eSBT       DBT as %         DBT live             DBT
                of all BTs      birth rate       multiple      of all BTs      birth rate        multiple
                                                birth rate                                      birth rate
    Up to 35          9.8%          42.8%            2.8%          85.5%          39.0%            42.8%
    35-39             8.3%          36.4%            4.5%          84.9%          33.5%            29.3%
    40+               5.0%          32.4%            8.3%          60.5%          25.1%            30.1%
Table: Elective single blastocyst transfer (eSBT) live birth rates and multiple births compared with
those of double blastocyst transfer (DBT) in 2004, 2005 and 2006. The number of live births in 2006,
and therefore the live birth rate, will increase because not all outcomes have yet been reported.


4.16 The small number of blastocyst transfer cycles on the HFEA Register means
     that it is not yet possible to fully assess the impact that the procedure has on
     live birth rates and multiple birth rates. Elective single blastocyst transfer, in
     particular, has only occurred in 407 cycles in 2004, 2005 and 2006 combined.
     However, early indications, supported by the literature from other countries,

8
  Elective single blastocyst transfers are those in which three or more blastocysts were created, one
transferred to the patient and one or more blastocyst frozen for the patient’s future use. This is a
cautious definition, so the data at the Table may under-estimate the number of eSBTs.




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      show that the transfer of one blastocyst in most patients eligible for this
      procedure results in relatively high live birth rates and low multiple birth rates.

4.17 Despite the increased use of blastocyst transfer, with most cycles involving the
     transfer of just one blastocyst, the number of blastocyst transfer cycles as a
     proportion of all cycles is still 9.2%, even in 2006. A number of centres have
     reported practical obstacles to setting up a blastocyst transfer service, most
     significant of which is the need for weekend staffing of laboratories which is not
     feasible in many centres. As a result, even if all blastocyst transfer cycles
     involved the transfer of one blastocyst, the low multiple birth rate associated
     with this procedure is unlikely to make a significant difference to the overall
     multiple birth rate following IVF.

5     Funding of IVF treatment

5.1 It is estimated that 20-25% of IVF cycles in the UK are funded by the NHS and
    has been so for the past few years, despite recommendations published in the
    NICE guideline9 that patients should be offered up to three cycles of IVF
    treatment. When the guideline was launched, in 2004, the then Secretary of
    State for Health, Dr John Reid, announced that the Department of Health
    expected all Primary Care Trusts (PCTs) to provide at least one full cycle of IVF
    in the short term, with full implementation of the guideline to come in the longer
    term. Three years down the line, there has been slow progress towards full
    implementation of the guideline. According to a recent Infertility Network UK
    (INUK) briefing, ‘there continues to be considerable variation in the number of
    cycles of IVF and the range of treatment funded by PCTs, and that social
    access criteria for IVF treatment vary considerably across England.’10

5.2 One key issue is the definition of a cycle of IVF treatment. The NICE guideline
    does not offer a precise definition of a cycle, though it does recommend the
    storage of surplus embryos and their use in frozen embryo transfers before a
    new stimulated cycle is commenced. At the launch of the NICE guideline, the
    Department of Health defined a cycle as, ‘a cycle in which a woman’s ovaries
    are stimulated to produce a number of eggs… embryos created and transferred
    to the woman. Viable embryos created in this process but not transferred at that
    stage are then frozen and may be transferred to the woman at a later stage’11.
    However, a recent INUK survey showed that, of the 50% of PCTs that
    responded to the survey, only 40% said that they fund frozen embryo transfer
    as part of an IVF cycle.

5.3 The Department of Health recently reminded PCTs of the definition of a full
    cycle and will be monitoring NHS provision of IVF closely from now on.


9
  Fertility: assessment and treatment for people with fertility problems National Institute for Clinical
Excellence, February 2004
10
   Facilitating the sharing of good practice in the implementation of the NICE guideline on the
assessment and treatment of people with fertility problems Infertility Network UK, 2007
11
   ‘Health secretary welcomes new fertility guideline’ Department of Health press release, 25 Feb
2004




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6    Data collection and reporting

6.1 The HFEA publishes outcome data for patients – on IVF/ICSI, IVF with donor
    eggs and donor insemination by clinic through – the Find a Clinic tool on the
    website. Through the tool, patients are able to see the live birth rate per cycle,
    the singleton, twin and triplet live birth rates per cycle and the implantation rate,
    all broken down into age bands. The image below shows the national statistics
    page from Find a Clinic as an illustration.




6.2 It is possible to compare this clinic information with the national averages by
    clicking on a clearly visible tab. By clicking on a different tab, patients can see
    the percentage of singleton, twin and triplet births as a proportion of all live
    births in the clinic and the proportion of single, double and triple embryo
    transfers as a proportion of all embryo transfers in the clinic. We do not
    currently allow patients to compare these proportions with the national average,
    though this could easily be done. The more significant outcome measures that
    we do not currently present are as follows:

          Live birth rates per egg collection (i.e. cumulative live birth rate following
           fresh and frozen embryo transfers)
          Live birth and multiple birth rates according to the number of embryos
           transferred
          Outcomes for elective single embryo transfer cycles (data set too small)
          Outcomes for blastocyst transfer cycles (data set too small)


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7     International comparisons

7.1 How does practice and policy in the UK compare with that of other countries?
    Looking at IVF across Europe, the UK seems to perform above average in
    some practices but below in others. The most recently published European
    data from 200312 shows the UK as ranking relatively well on live birth rates (3rd
    of 19 countries reporting more than 50 live births), relatively poorly on multiple
    births (the 8th highest multiple births rate of 10 countries) and poorly on the
    proportion of single embryo transfers (17th of 19). Good live births rates aren’t
    necessarily dependent upon a higher multiple birth rate, however. Sweden,
    which in 2003 had the greatest use of SET and the lowest multiple birth rate,
    still ranked 4th on live birth rates. Sweden’s multiple birth rate is now below 5%.

7.2 Policy across Europe varies enormously. In Belgium, where single embryo
    transfer is linked to generous state funding of IVF, twin rates have fallen by
    50% and significant neonatal cost savings have been made, which in turn fund
    the cost of increased state funding. In Sweden and Finland, the push towards
    single embryo transfer has come more from practitioners. In 2003, the Swedish
    government set a framework in which SET should be the norm. However,
    practitioners themselves developed the patient selection criteria. In Finland,
    there was no regulatory push towards SET, with practitioners taking this
    approach themselves from 2000 onwards.

7.3 In the United States and Australia, professional guidelines on the number of
    embryos to be transferred are in place. In the US, professional guidelines
    recommend the transfer of no more than five embryos, with lower limits for
    particular age groups and those having blastocyst transfer13. Good prognosis
    patients under 35 years, for example, should have only one blastocyst or 1-2
    cleavage-stage embryos transferred.

7.4 During 2004, clinics in the United States achieved an average live birth rate
    following fresh IVF/ICSI of 27.7% (22.1% in the UK) with a multiple birth rate of
    32.5% (23.6% in the UK). In the USA, 8.2% of fresh embryo transfers used one
    embryo, 39.4% two embryos and 31.8% three embryos, with the remaining
    20.6% involving four or more embryos. In the UK during 2004, 11.1% of
    transfers used one embryo, 83.8% two embryos and 5.1% three embryos.

7.5 In Australia, Fertility Society of Australia guidance14 requires all centres to
    minimise the incidence of multiple births following IVF and to transfer no more
    than two embryos to women under 40 years. It also recommends that women
    under 35 years on their first fresh treatment have no more than one embryo
    transferred.


12
   ‘Assisted reproductive technology in Europe, 2003: results generated from European registers by
ESHRE’ Nyboe Anderson A et al Human Reproduction (2007) Volume 22 No. 6, pp1513-1525
13
   ‘Guidelines on number of embryos transferred’ ASRM Practice Committee Fertility and Sterility
86:suppl.4, November 2006
14
   Code of Practice for Assisted Reproductive Technology Units Fertility Society of Australia
Reproductive Technology Accreditation Committee, February 2005




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Section C: Findings from the consultation
1     Multiple births and single embryo transfer consultation

1.1 The Multiple births consultation sought to gather the experiences and views of
    a range of stakeholders, focused around four possible policies designed to
    reduce the incidence of multiple births following IVF. The elements of the
    consultation were:

           A written consultation document with a questionnaire
           Three patient focus groups
           One consultation meeting with practitioners and one with patients

1.2 The breakdown of participants in the consultation was as follows:

                          Focus        Pract-       Patient        Written            All      All %
                         groups       itioner      meeting      responses
                                     meeting
 Patients                     24                           9           719           752         82.9
 Non-IVF parents                                                        15            15          1.7
 Fertility doctor                           16                          29            45          5.0
 Fertility nurses                            8                          12            20          2.2
 Embryologists                              11             1            12            24          2.6
 Counsellors                                                              8            8          0.9
 Paediatricians                                                           1            1          0.1
 Commissioners                                                          19            19          2.1
 Other                                       4             2            62            68          7.5
 Organisations                                             3            18            21          2.3
 All participants             24            39           15           829*          907*        100*
Table: Participants in the multiple births consultation by participant group and consultation element.
*The total is less than the sum of the participant groups because some respondents chose more than
one group.

The written consultation document
1.3 The consultation document, The best possible start to life, made it clear that the
    HFEA intends to do something to reduce the incidence of multiple births, but is
    open about what that something should be. The document described the risks
    caused by multiple births to IVF children and their mothers as ‘avoidable’ and
    ‘unacceptably high’. ‘IVF practice needs to change in order to give IVF children
    better chances to be born at full term and with a normal birth weight – a better
    start to life.’ The document said that the multiple birth rate should be reduced
    from the current rate of 23% of all live births following IVF to below 10%.

1.4 The document presented four options for reducing the incidence of multiple
    births following IVF and invited views on their acceptability. The options were:




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          1: HFEA to work with clinics, patients and professional bodies to increase
           awareness of the risks of multiple births and to encourage increased use
           of single embryo transfer
          2: HFEA to set a maximum twin rate of no more than 10 percent, that
           each clinic must not exceed, which could be phased in over a number of
           years
          3: Develop Code of Practice guidance that defines in which cases only
           one embryo should be replaced, based on, for example, age, number of
           previous treatment cycles, medical history and possibly embryo quality
          4: A combination of options 2 and 3 above, i.e. clinics could initially be
           given an overall maximum twin birth rate. If they fail to achieve it, they
           have single embryo transfer criteria imposed on them by the HFEA

1.5 The document was followed by a questionnaire which stakeholders were invited
    to complete. The questions were as follows:

          Do you think there is too much, not enough or the right degree of
           emphasis on the health risks for twins and their mothers?
          Who do you think should decide which women should have just one
           embryo transferred: the HFEA through guidance to clinics; professional
           bodies through recommendations to fertility practitioners; only the doctor
           in discussion with the patient?
          Do you think the current HFEA guidance on embryo transfer is essentially
           OK; too strict and limits women’s chance of conceiving: not strict enough
           and allows the high number of twin pregnancies to continue?
          Which of the four policy options [listed at 1.4] do you prefer?

1.6 Respondents were also asked to pick which, of a list of factors identified by the
    Expert Group, they considered to be obstacles to the introduction of single
    embryo transfer in the UK. Finally, respondents were given the opportunity to
    give any further views or comments at the end of the questionnaire. A full report
    on the written consultation responses is at Annex A.

Consultation meetings
1.7 Two consultation meetings were held in London: one for practitioners on 11
    June and one for patients on 23 June. The aim of the meetings was to
    understand more about the experience of clinic staff and patients and their
    attitudes towards single embryo transfer. Summaries of the meetings are at
    Annexes B and C.

Patient focus groups
1.8 The HFEA commissioned Opinion Leader to conduct three patient focus groups
     in order to understand patient views in more depth. These groups were held in
     London, Bristol and Glasgow in May 2007 and consisted of six prospective
     patients (Bristol), six patients who had had unsuccessful treatment (Glasgow)
     and six IVF parents, some with singleton babies and some with twins (London).
     A summary of the views expressed at the focus groups is at Annex D.




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2    General feedback through the consultation

Information provision to patients
2.1 What are patients currently told about the risks of multiple births and the
     possibility of having just one embryo transferred during IVF treatment? As
     discussed above, the HFEA’s current guidance requires clinics to provide
     patients with information about the chance of conceiving a multiple pregnancy
     and the risks associated with multiple pregnancy and delivery. We know that
     clinics produce this information for their patients, but it is much more difficult to
     tell how much patients absorb this information.

2.2 As the pie charts below show, most patients responding to the written
    consultation felt that they had enough information on the risks of multiple births.
    In fact, 24% felt that the risks were over-emphasised. Meanwhile, nearly half of
    the IVF practitioners (fertility doctors, fertility nurses, embryologists and
    counsellors) thought that there is too little emphasis on the risks associated
    with multiple births.


                        11%
                                                                      18%
      24%




                                     Not enough emphasis
                                     The right degree of emphasis                              43%

                                     Too much emphasis




                                                                    39%
                         65%



             Patients                                                       Practitioners



2.3 Of the 99 (18%) respondents who chose the option ‘Too much emphasis’, most
    did so because they thought that the risks associated with twins are over-stated
    or that all pregnancies, whether singleton, twin, IVF or non-IVF have risks
    associated with them.

2.4 Would more or better information increase the uptake of single embryo
    transfer? In August 2006, members of the HFEA Fertility Views panel were
    asked whether they had received information about the risks associated with
    multiple births. Of 481 respondents who had seen a medical practitioner about
    their fertility problem, 346 (72%) received information about the risks of multiple
    births. However, of those 346, only 31 (9%) changed their mind about embryo




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      transfer as a result of receiving the information. One British study15 confirmed
      this finding. Compared to standard information provided to IVF patients, neither
      the addition of an extra leaflet about the risks of multiple births nor a 10-minute
      discussion with a member of staff changed patient attitudes towards multiple
      pregnancy and single embryo transfer.

2.5 Those who attended the consultation meetings and focus groups felt that how,
    when and by whom information is presented to patients matters as much as
    what the information says. Another information requirement for patients is what
    can be done to reduce the chance of conceiving a multiple pregnancy. A
    number of participants in the patient focus groups said that they had plenty of
    information from their clinics about the risks associated with multiple
    pregnancy, but very little about SET as a viable way of reducing the chance of
    having a multiple pregnancy without reducing the chance of conceiving.

Patient attitudes towards multiple births and single embryo transfer
2.6 The HFEA Register data show that UK clinics have not moved towards single
     embryo transfer in a significant way. The literature and the evidence from the
     consultation show that patients and IVF practitioners are reluctant to do so in
     the near future. This reluctant was confirmed by an August 2006 Fertility Views
     patient survey, in which the majority (57%) of respondents said that they would
     not agree to single embryo transfer if their medical practitioner advised it.

2.7 Why do patients seem to be resistant to single embryo transfer? One common
    explanation is that patients prefer to have twins. One Canadian study16 showed
    that 41% of patients see twins as an ideal outcome, although this desire
    reduced when patients had existing children, had undergone treatment before
    and the longer the duration of their infertility was. A British study17 showed a
    similar pattern: 60% said they preferred a singleton baby (though this rose to
    about 70% on receipt of further risk information).

2.8 Preliminary findings from the September 2007 Fertility Views survey show that
    a significant proportion of patients would like to have twins. When asked about
    the desirability of a singleton, twin or triplet birth, 76% thought that a singleton
    birth was desirable or very desirable and 56% thought that a twin birth was
    desirable or very desirable. However, the vast majority of patients felt that any
    live birth, regardless of the number of babies, was desirable or very desirable.

2.9 The respondents to the consultation were not asked whether they preferred
    twins. However, in question 6, they were asked to rank a list of potential
    obstacles to greater use of SET, one of which was a preference for twins. The
    same proportion of patients and IVF practitioners (31%) it was an obstacle,
    although patients ranked it 3rd, whilst practitioners ranked it 7th.

15
   ‘A randomized comparison of alternative methods of information provision on the acceptability of
elective single embryo transfer’ Murray S et al Human Reproduction (2004) 19:911-916
16
   ‘The desire for multiple pregnancy in male and female infertility patients’ Child et al Human
Reproduction (2004) 19:558-561
17
   Murray et al Human Reproduction (2004)




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2.10 Patients are primarily concerned about reduced live birth rates following single
     embryo transfer: if the alternative is not to conceive at all, twins, even with
     significant health problems, are preferred by most patients18. Because of the
     social eligibility criterion applied by many PCTs (endorsed by John Reid in his
     press statement) that people with a child do not qualify for NHS-funded
     treatment, a twin delivery is perceived as a desirable outcome for those who
     would like to have more than one child.

2.11 The Expert Group suggested that ‘patients and their clinicians are likely to
     resist even the smallest reduction in pregnancy rates if they believe that this is
     their sole chance of a pregnancy’. The impression from the consultation is that
     this attitude applies to all IVF patients, regardless of how many cycles they are
     able to access. The focus group discussions highlighted patients’ frustration
     with the relatively low success rate following IVF. Some felt that the HFEA’s
     primary goal should be to raise success rates before we tackle multiple births.

2.12 The evidence seems to suggest that, regardless of whether patients actively
     seek to get pregnant with twins or they see a twin birth as an acceptable side-
     effect of IVF, their attitude towards multiple births is shaped by their perception
     and experience of IVF itself. In the context of the high cost of treatment, the
     paucity of NHS-funded fertility services, the unpleasantness of the procedure
     and its perceived low success rate, not to mention the effect of advancing age
     on the ability to conceive, multiple pregnancy and all its attendant risks seems
     by most patients to be an acceptable outcome of treatment.

Financial considerations
2.13 The financial aspects of treatment are a significant consideration for patients
     when thinking about the number of embryos to transfer. In the August 2006
     Fertility Views survey, 75% of those who said that they would not consider
     single embryo transfer if their medical practitioner advised it, said that they
     would be more likely to consider it if NHS funding for three cycles of IVF were
     routinely available. This finding is echoed in the Murray study which showed
     that patients would be more inclined to accept eSET if they paid a fixed price
     for treatment which included frozen embryo transfers.

2.14 At the focus groups, patients were primarily concerned about their ability to
     conceive if SET became mandatory for certain patients and were worried about
     the prospect of having more than one treatment cycle (particularly prospective
     patients). However, the lack of NHS treatment and the cost of treatment for
     private patients exacerbated the problem in their eyes. Full implementation of
     the NICE guideline would increase acceptance of SET for these patients.

2.15 The patient respondents to the written consultation were also primarily
     concerned about the effect that single embryo transfer might have on their
     ability to conceive at all. Again, their concerns were exacerbated by the lack of


18
  ‘Safety versus success in elective single embryo transfer: women’s preferences for outcomes of
IVF’ Scotland GS et al British Journal of Obstetrics and Gynaecology (2007) 114(8): 977-983




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       availability of NHS funding and the consequent need of most patients to pay for
       treatment themselves. Respondents were presented with a list of 12 obstacles
       to change identified by the Expert Group and were asked to indicate which they
       felt were indeed obstacles to increased use of single embryo transfer in the UK.
       The lack of NHS funding for IVF was by far the biggest concern, with 70% of
       patients and 61% of IVF practitioners identifying it as an obstacle to
       implementation of SET (the full response is at Annex A, Question 6).

2.16 Some patients were concerned about the impact that single embryo transfer
     would have on those lucky enough to qualify for NHS funding, but whose PCT
     did not include frozen embryo transfers in the cycle(s). However, most were
     disgruntled about the wider funding context in which few PCTs are providing
     the recommended three cycles of IVF. As a result of this, patients feel poorly
     served by the NHS and react negatively to justifications for single embryo
     transfer which refer to multiple births as a financial drain on the NHS. NHS
     patients want to exert whatever control they can over their treatment, in order to
     feel that they have gained maximum benefit from what is available to them.

Patient choice and clinical freedom
2.17 The overwhelming concern for patients was that wide use of single embryo
     transfer would mean a greater restriction on their choice. When asked who
     should decide which women have just one embryo transferred during IVF, 73%
     answered ‘only the clinician in discussions with the patient’, whilst 6% said ‘the
     HFEA through guidance to clinics’.

2.18 However, most respondents to the written consultation felt the current HFEA
     guidance was about right (59% of all respondents to the question; 61% of
     patients and 47% of IVF practitioners), suggesting an acceptance of some
     limits to clinical freedom and patient choice. However, some felt that the current
     guidance is too strict (28% of all respondents; 31% of patients and 15% of IVF
     practitioners). Separating the responses into those from patients and
     practitioners, the proportions changed significantly, as the pie charts show.


          11%
                                                                   17%
   3%

  3%
                                    Only the clinician in
                                    discussion with the
                                    patient
                                    Professional bodies
                                    HFEA through guidance   17%
                                    Other                                                    55%




                           83%                                    11%



                Patients                                                 Practitioners



2.19 However, IVF practitioners were also keen to maintain some clinical freedom in
     deciding about the number of embryos to transfer. The majority of IVF


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     practitioners (47%) preferred the decision about who should qualify for single
     embryo transfer to be one for the clinician and patient, with the second most
     favoured approach being HFEA guidance (15%).

‘League’ tables
2.20 As described in 2.15 above, respondents to the written consultation were
     presented with a list of 12 factors and were asked to indicate which they felt
     were obstacles to increased use of single embryo transfer in the UK. Whilst
     patients did not rank ‘HFEA outcome data presentation’ and ‘Competition
     between clinics’ highly (these obstacles were chosen by 19% of patients,
     ranking them joint 8th), IVF practitioners saw them as much more problematic.
     The top five obstacles for practitioners were as follows (respondents could
     choose more than one obstacle):

          The lack and inconsistency of NHS funding (61%)
          The lack of UK data on elective single embryo transfer (52%)
          Competition between clinics (44%)
          HFEA outcome data presentation (38%)
          The lack of understanding about the risks of multiple births (37%)

2.21 Many IVF practitioners, both responding to the written consultation and
     contributing to the consultation meeting, were keen to point out the realities of
     working in a predominantly private IVF sector. Because patients paying for their
     own treatment choose a clinic based upon its live birth rate, competition
     between clinics for business is a significant issue. This led many practitioners to
     express a desire for two competing approaches. On the one hand, they want
     the clinical freedom to be able to pick the best patients for single embryo
     transfer. On the other, because of the competitive climate in which many of
     them work, they want a level playing field, to avoid a situation in which clinics
     carrying out very few single embryo transfers are rewarded by having a higher
     live birth rate (thereby attracting more business) than those taking serious steps
     to reduce their multiple birth rate.

Summary of general feedback from the consultation
2.22 Patients seem to understand the risks associated with twins, but they are
     deeply concerned about the prospect of single embryo transfer. This is not
     because they want twins necessarily (although some clearly do), but because
     they feel SET will worsen what they consider to be their already low chance of
     conceiving. In this context, many patients are prepared to run the risk of
     conceiving twins following double embryo transfer.

2.23 Practitioners’ views are harder to establish, mainly because they make up such
     a small proportion of respondents to all the different strands of the consultation
     (10.6% overall and 7.4% of respondents to the written consultation). The overall
     impression is that practitioners take the risks associated with multiple births
     seriously and do seek to ensure that their patients are aware of those risks.
     Most practitioners accept that wider use of single embryo transfer is inevitable,
     but very few clinics have moved to eSET for good prognosis patients under
     their own steam, except for those offering blastocyst transfer.



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2.24 The main reason for this reluctance is poor NHS funding of IVF. Clinics fear
     that they will disadvantage their NHS patients and increase the cost of
     treatment for their private patients if they move to eSET for good prognosis
     patients. But practitioners are also concerned about the way that the HFEA
     presents clinic outcome data. Because most clinics are competing for patients,
     they want to maximise their live birth rate per cycle and, by so doing, achieve
     as high a position in the ‘league table’ as is possible. In such an environment,
     moving towards single embryo transfer, with its impact upon live birth rates per
     cycle, is not a feasible option from a business perspective, unless a guidance
     approach is adopted, thereby creating a level playing field.

2.25 However, from a clinical perspective, IVF practitioners want to do what is best
     for their patients. For most practitioners, this means maintaining the clinical
     freedom to choose themselves, in consultation with the patient, which women
     are most suited to having just one embryo transferred. This creates a tension
     when considering whether the HFEA should take a light touch approach (to
     meet clinical demands) or produce guidance in order to create uniformity
     across all clinics (to meet business demands).

3    Stakeholder views on the policy options

3.1 How do all of the views and concerns expressed by stakeholders translate into
    attitudes towards the policy options presented? The options were:

          1: HFEA to work with clinics, patients and professional bodies to increase
           awareness of the risks of multiple births and to encourage increased use
           of single embryo transfer
          2: HFEA to set a maximum twin rate of no more than 10 percent that each
           clinic must not exceed, which could be phased in over a number of years
          3: Develop Code of Practice guidance that defines in which cases only
           one embryo should be replaced, based on, for example, age, number of
           previous treatment cycles, medical history and possibly embryo quality
          4: A combination of options 2 and 3 above, i.e. clinics could initially be
           given an overall maximum twin birth rate. If they fail to achieve it, they
           have single embryo transfer criteria imposed on them by the HFEA

Views expressed at the patient focus groups
3.2 The view expressed at the patient focus groups was that Option 1 was the
    preferred approach. Some acknowledged that this approach may not have a
    significant impact upon multiple birth rates, but they felt that this should be
    monitored by the HFEA and, if necessary, the policy could be reviewed in light
    of this.

3.3 Most participants were worried that if Option 2 were adopted, the clinics might
    put achieving the target above choosing the most appropriate treatment for
    their patients.

3.4 Option 3 caused a little confusion because most participants assumed that
    HFEA guidance was more advisory than restrictive. Patients were in favour of a
    consistent approach across clinics, but once they understood that the guidance
    approach would be relatively rigid, they became concerned that individual


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     patients might be disadvantaged. They felt that the criteria could never be
     sensitive enough to mean that each patient got the number of embryos most
     suitable for their individual case. Patients thought that if the guidance were to
     be more flexible, some of their concerns could be addressed.

3.5 Option 4 was rejected by all participants because they felt that there was no
    room for patient decision-making and that it had the disadvantages of Options 2
    and 3.

Views expressed at the patients’ consultation meeting
3.6 At the patients’ consultation meeting, the delegates were divided into two
    groups so that the options could be discussed in detail. Unlike the patients
    attending the focus groups or responding to the written consultation, most
    patients attending this meeting felt that there is not sufficient information given
    to patients about the risks associated with multiple births. This is probably
    because they were presented at the meeting with detailed information about
    these risks by Jane Denton of the Multiple Births Foundation. By contrast, other
    patient respondents were given written information.

3.7 As a result, patients at the consultation meeting felt that Option 1 was a positive
    approach to take, rather than being the least bad option (a view taken by many
    focus group participants). However, although Option 1 was widely endorsed,
    any policy which sought to restrict patient decision-making was generally
    frowned upon.

3.8 Patients were very concerned that by setting a target (Option 2), those clinics
    who reached their target early on in the year would only transfer one embryo to
    all patients to ensure that they were not penalised for exceeding the twin rate.
    There were also concerns about clinics only selecting good prognosis patients
    to ensure that in doing SET their success rates don’t fall. Patients felt that
    Option 3 gave clear limits, but were concerned that it was not flexible enough. If
    Options 2, 3, or 4 were adopted, patients at the meeting felt that success rates
    should be closely monitored and the policy reviewed if they were seen to fall.

Views expressed at the practitioners’ consultation meeting
3.9 At the practitioners’ meeting, delegates were divided into groups and asked to
    discuss both what practitioners could do to reduce the incidence of multiple
    births and what the HFEA could do to help bring this about. A number of
    recommendations, listed at Annex B, were made.

3.10 Delegates were also asked to give their opinion of the policy options. Three of
     the four discussion groups felt that Option 1 should be adopted regardless of
     the outcome of the consultation. However the majority felt that sanctions would
     be necessary to ensure that the multiple birth rate was reduced. One group felt
     that Option 1 would be very unlikely to have an impact on the multiple birth rate.

3.11 There was some concern that Option 2 would be difficult to implement and
     delegates were unsure how the maximum twin rates could be controlled. Option
     4 was not popular amongst delegates, although one of the four groups
     preferred this approach because it made up for the disadvantages of Options 2
     and 3.


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3.12 Most delegates felt that Option 3 was the most enforceable approach and
     would create a level playing field for clinics. However, concerns were raised
     that Option 3 allows the least amount of flexibility and clinical discretion.
     Delegates said that, if this approach were adopted by the HFEA, the selection
     criteria for SET should be simple and workable.

3.13 Whichever policy option was chosen by the Authority, delegates felt that a
     generous amount of time for implementation should be given.

Views expressed through the written consultation
3.14 Respondents to the written consultation were asked in Question 5 to choose
     their preferred policy for reducing the incidence of multiple births following IVF
     or to pick ‘none of the above’. They were also asked to give reasons for their
     choice. The pie chart below shows the proportions of respondents to the
     question (759) who chose each option.



                              24%


                                           Option 1

                                           Option 2
      45%
                                           Option 3
                                     3%
                                           Option 4

                                           Other


                                16%



                       12%




3.15 Because so many of the respondents chose ‘None of the above’, we examined
     the reasons they gave for choosing this option and have created a separate
     category for ‘Maintain the status quo’, keeping those who did not give a reason
     for choosing ‘None of the above’ and those who gave other reasons besides
     wanting to retain the status quo in a ‘None of the above’ category. Recast in
     this way, the proportions favouring each option are as follows:

                  5%

                               24%




                                             Option 1
                                             Option 2
                                             Option 3
     40%                              3%
                                             Option 4
                                             Status Quo
                                             Other

                                    16%




                        12%




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3.16 When asked to give reasons for their choice, those who chose Option 1 and
     gave a reason (111 respondents) were most likely to think that decision-making
     about the number of embryos to transfer should either be on a case-by-case
     basis or should be left entirely to the patient, based upon clinical advice. A
     small number of respondents thought patients should be given better
     information about the risks associated with multiple births. Finally, smaller
     numbers thought either that SET would reduce success rates or that the lack of
     NHS funding and the expense of treatment means that it should be a matter of
     patient choice.

3.17 Those who chose Option 2 and gave a reason were very small in number (10
     respondents). However, most of those felt that flexibility about the number of
     embryos to be transferred is desirable and that Option 2 goes some way to
     achieve this.

3.18 Option 3 was preferred by 16% of respondents to the question. However, from
     examining their reasoning, it is clear that some did not understand the weight of
     HFEA guidance and assumed instead that it amounts to advice to clinics. That
     respondents misunderstood the meaning of guidance is reinforced by the fact
     that many showed their preference for relatively unrestricted patient choice
     through answers to the other questions.

3.19 Most of the respondents choosing Option 4 and giving a reason for doing so
     (39) gave the same reasons as those choosing Option 2: that decisions should
     be case-by-case and flexibility should be maintained.

3.20 As shown above, the majority of respondents to the question chose ‘none of the
     above’, of which 304 seemed to opting for the status quo. When asked to give
     reasons, nearly half said that decisions should be case-by-case or solely taken
     by patients and just under one fifth said that the current situation is acceptable.




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Section D: Analysis of the policy options
1    General ethical principles/policy objectives

1.1 As outlined above, the aim of the Multiple births review was to ‘work closely
    with a range of patient and professional stakeholders and experts to assess
    whether and under what conditions single embryo transfer is a viable option for
    reducing the twin birth rate in the UK, without significantly impairing success
    rates’. At its February 2006 meeting, the Expert Group on Multiple births added
    to these aims by agreeing a number of policy objectives by which any new
    policy on multiple births could be assessed:

            that the number of multiple births following IVF is reduced, thereby
             reducing the morbidity and mortality of mothers and babies;
            that the cost of treatment for patients does not increase significantly;
            that success rates are maintained as much as possible;
            that other aspects of patient care are not compromised;
            that doctor/patient decision-making is respected as much as possible;
            that the HFEA is not drawn into the autonomy of clinical decision-making;
            that clinics are encouraged to develop better embryo selection practices;
            that the costs to the NHS of multiple births are taken into consideration.

1.2 The aim of the review and the policy objectives listed above provide a good set
    of criteria by which to judge the success of the review. However, there are
    broader ethical and regulatory principles which might inform the way the HFEA
    responds to the issue of multiple births. Considering the issue in terms of good
    regulation may help. The principles of good regulation are as follows:

 Proportionality   Policy solutions should be appropriate for the perceived problem or risk

 Accountability    Regulators must be able to justify the decisions they make

 Consistency       Government rules and standards must be joined up and implemented fairly and
                   consistently

 Transparency      Policy objectives, including the need for regulation, should be clearly defined
                   and effectively communicated to all stakeholders

 Targeting         Minimise side-effects and ensure that no unintended consequences will result
                   from the policy


2    Proportionality and risk

2.1 Seen in terms of proportionality, what level of risk to patients and their babies is
    required in order to justify intervention by the HFEA? And should HFEA
    intervention be based upon individual risk of harm or upon public health harms?

2.2 Most people accept the current policy of limiting the number of embryos to two
    or three, depending upon the age of the patient. Respondents to the written
    consultation were asked whether they thought that the current HFEA guidance
    on embryo transfer was about right, too strict or not strict enough. Across all


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     respondents, 62% thought that the guidance was about right, with 30% thinking
     that it is too strict. The answers were similar for patients alone, however IVF
     practitioners were more likely than patients to think that the guidance was not
     strict enough (65% said about right and 32% said not strict enough).

2.3 In summary, 82% of practitioners and 68% of patients thought that the current
    guidance is either about right or is not strict enough, suggesting a broad
    acceptance of current intervention by the HFEA to limit the numbers of embryos
    transferred in order to minimise the proportion of triplet births. This acceptance
    is probably based upon an assessment of individual risk. The chance of
    problems arising in a triplet pregnancy and birth is high and the problems are
    likely to be serious. In addition, by setting a limit of two embryos for women
    under 40, the chance of conception after one fresh cycle is not significantly
    reduced.

2.4 The number of triplets born when three-embryo transfers were common,
    however, was relatively low: at the peak in 1998, there were 163 sets of triplets
    out of 6323 live births. So, the reduction in the incidence of triplet births
    following IVF has not led to significant public health savings.

2.5 When it comes to the possibility of limiting the number of embryos transferred
    to one for selected patients, the issue of individual versus public health risk is
    more difficult to resolve. Although the chance of conceiving twins after IVF is
    much higher than triplets, the likelihood of serious medical problems arising in a
    twin pregnancy or delivery is significantly lower. For a woman under 35 years
    starting treatment, the chance of conceiving twins is 7.5%. It may be
    understandable, therefore, that someone in this position might view the chance
    of conceiving twins and of one or both of those twins having serious health
    problems as negligible.

2.6 However, because so many twins are born following IVF (1930 twin births out
    of 8234 live births in 2005), the public health impact of all those twins together
    is significant. Should HFEA seek to reduce the incidence of twins following IVF
    in order to reduce the risks associated with all IVF twins in total, or to reduce
    the level of risk that individual couples are exposed to. If it is to be the latter,
    one respondent to the written consultation, the British Medical Association,
    argued that the risks associated with twin pregnancies are not high enough to
    warrant HFEA intervention:

           ‘Although the BMA supports efforts to reduce the number of twin
           pregnancies… [we are] not convinced that the level of risk associated with
           twin pregnancies is sufficiently high to override the autonomous choice of
           informed patients, in consultation with their health care team, to have two
           embryos replaced. In order to justify regulatory action to override patients’
           autonomy, there must be overwhelming evidence of serious harm – we
           are not convinced that the current evidence in relation to twin pregnancies
           meets this level.’

2.7 Ultimately, the Authority needs to make a judgement about the balance of risks
    and benefits of the various policy options presented below.



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3     Assessing the policy options

3.1 We have seen how respondents to the consultation – through the focus groups,
    the written consultation and the consultation meetings – have reacted to the
    policy options. But stakeholder attitudes is only one factor to be taken into
    account when deciding upon the appropriate course of action. Below is a table
    of considerations which might help the committee assess the appropriateness
    of each of the policy options:

 Feasibility     Will it reduce multiple births whilst maintaining live birth rates?

 Acceptability   What are stakeholders’ attitudes towards it?

 Practicality    How workable is it in terms of implementation, inspection and enforcement?

 Impact upon     How will it change patients’ experience of treatment: the cost of treatment, the
 patients        amount of treatment required and the length of time taken to conceive?

 Regulatory      What is the financial and administrative burden of each of the policy options?
 burden


Feasibility
3.2 The Expert Group considered the literature and the experience in countries
     which have adopted single embryo transfer and concluded that, in general,
     single embryo transfer in the right patients can significantly reduce the
     incidence of multiple births following IVF whilst achieving comparable live birth
     rates to double embryo transfer, particularly when frozen follow-on cycles are
     included to give a cumulative success rate.

3.3 There is no data showing the impact that eSET might have on patients in UK
    clinics. A randomised controlled trial was initiated in 2005 but was abandoned
    when the participating centres were unable to recruit patients to the study. As
    discussed above, the data set in the HFEA Register on elective single embryo
    transfers is too small to be analysed. One study, TowardSET, aims to analyse
    UK double embryo transfer data to develop a statistical model for selecting
    patients for eSET. However, the findings of this study will not be available until
    the end of 2008.

3.4 However, whilst many patients at the focus groups were unconvinced of the
    applicability of data on Swedish or Finnish patients to patients in the UK, there
    are no reasons to assume that patients in UK clinics will respond significantly
    differently from those in other countries. What makes the UK different is the
    context in which treatment takes place (NHS funding, competition between
    clinics etc.) which has a knock-on effect upon the acceptability of SET from the
    point of view of the various stakeholders.

Practicality
3.5 Regulation Committee discussed the practicalities of the four policy options at
     its July and September meetings, bearing in mind the following factors:




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             Risk assessment: how easily will inspectors be able to identify high or low
              risk clinics for the purpose of deciding when an ‘inspection holiday’ can be
              given?
             Inspection: how easily will inspectors be able to check compliance on or
              before inspection?
             Enforcement and sanctions: if a clinic is not complying, will a Licence
              Committee be able to make a judgement on the reasonableness of the
              clinic’s actions and what sanctions will it use, if necessary?

3.6 In summary, Regulation Committee considered all of the policy options to have
    some disadvantages in terms of risk assessment, inspection and enforcement.
    Their discussion of the advantages and disadvantages of each of the policy
    options are included in the tables below under ‘Practicality’. The committee
    recommended the addition of an Option 5, in which centres would be required
    to develop their own patient selection criteria for SET. This policy option seeks
    to maximise the advantages of Options 1 and 2, whilst minimising their
    disadvantages.

Impact upon patients
3.7 As discussed above, roughly 75% of IVF cycles take place in the private sector,
    meaning that roughly 24,750 cycles each year are funded by the patient
    themselves. The cost of a fresh IVF treatment ranges from £4,000 to £8,000.
    Keeping the embryos longer in the laboratory and transferring them at
    blastocyst stage costs patients about £400 extra, though some clinics do not
    charge for this. Frozen embryo transfers cost about £1000 and embryo freezing
    plus storage costs roughly £300. Of the 8250 (25%) NHS-funded cycles each
    year, it can be estimated that 40% are full cycles which include storage and
    frozen embryo transfers19. A variety of social eligibility criteria also apply.

3.8 Since single embryo transfer is likely to mean increased use of frozen embryo
    transfer in order to use embryos created from one egg collection, this will result
    in increased costs for private patients and reduced success rates for NHS
    patients who are not funded for a full cycle. The cost of treatment is only one
    impact upon patients, however. Treatment is invasive and stressful and
    involves time off work and, possibly, the need to travel some distance.

Regulatory burden
3.9 One of the goals of better regulation is to avoid imposing unnecessary
    regulation on regulated institutions, particularly small businesses. One way of
    assessing necessity is to balance the cost of the proposed regulations upon
    clinics with the benefit which is likely to be gained from them. Therefore part of
    the assessment below of each of the policy options includes consideration of
    the regulatory burden.




19
     This estimate is based upon an INUK survey of PCTs which had a response rate of 50%.




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Summary
3.10 Each of the four policy options put out to consultation are examined in more
     detail below. Although most respondents to the written consultation reject the
     four options in favour of the status quo, we have not included this below
     because HFEA has already made a policy decision to act to reduce the
     incidence of multiple births following IVF. However, we have added a fifth
     option following discussion at Regulation Committee.




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4    Option 1: HFEA to work with clinics, patients and professional bodies to
     increase awareness of the risks of multiple births and to encourage
     increased use of single embryo transfer

4.1 Following recommendations from the Expert Group on Multiple births, the
    HFEA stated in its consultation document, The best possible start to life, that
    doing nothing was not an option. However, it was agreed that HFEA guidance
    was not necessarily the only approach to reducing the incidence of multiple
    birth. Option 1, therefore, presented respondents with a non-regulatory
    approach which would seek to both increase awareness of the risks of multiple
    births but also to encourage (rather than to require) clinics to carry out more
    single embryo transfer cycles.

4.2 In practice, Option 1 is likely to mean the following:

          HFEA reminds clinics of the requirements in the current guidance to
           inform patients of the risks of multiple births
          Consent forms could be changed to include a tick-box showing that the
           patients has been provided with the appropriate information on multiple
           births
          HFEA publishes a statement that it would like to see increased use of
           elective single embryo transfer for suitable patients and lower multiple
           births rates across all centres
          HFEA works with patient organisations to improve its patient literature on
           multiple births, including patient information sheets, the Guide to Infertility
           and the ‘soft’ information surrounding the Find a Clinic tables on the HFEA
           website
          HFEA makes changes to the presentation of outcome data, such as:
           publication of elective single and double embryo transfer cycles across all
           centres (not by centre) to enable patients to compare their chance of a
           live birth depending upon the number of embryos transferred; publication
           of blastocyst cycle data by number of blastocyst transferred across all
           centres; more prominent presentation of each centre’s multiple birth
           proportion and how it compares to the national average; presenting
           cumulative success rates based upon fresh and frozen transfers.

4.3 One practitioner suggested that HFEA should revise its fee structure (which
    currently charges the same whether the treatment involves fresh or frozen
    embryos) to incentivise clinics and patients to use more frozen embryo
    transfers.

Feasibility
4.4 Because Option 1 is voluntary in nature, it is difficult to know how many clinics,
     will recommend single embryo transfer to their patients and to what extent.
     Some patient participants in the consultation chose Option 1 precisely because
     they felt it would have a limited impact upon current practice. A number of
     practitioners at the consultation meeting chose Option 3 for the same reason:
     because clinics are unlikely to substantially change their practice if Option 1
     alone were adopted.



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4.5 However, with improved information and better methods of delivering that
    information, both on the risks associated with multiple births and the possibility
    of single embryo transfer, requests from patients for single embryo transfer may
    increase over time. Patients at the focus groups felt that this option should be
    attempted, even if expectations about effectiveness are low. Monitoring of
    effectiveness should be carried out after one year and a more stringent policy
    could be considered if multiple birth rates have not fallen. Regulation
    Committee, too, felt that a ‘sunset clause’ would be sensible.

Acceptability
4.6 As discussed above, across all the different methods used during the
    consultation, Option 1 was the most popular option.

Practicality
4.7 When discussing the practicality of Option 1, Regulation Committee felt that it
     would be straight forward to strengthen the information requirements in the
     Code of Practice and that compliance with such an additional requirement
     would be easy to check through pre-inspection submissions and on inspection.
     If consent forms were to be amended, inspectors could check that the new
     forms were being used in clinics.

4.8 Difficulties would arise with clinics which are resistant to change. They may
    amend their patient literature, thereby complying with the Code, but may do
    little to encourage suitable patients to have single embryo transfer. It may be
    possible to identify those clinics by looking at their multiple birth rate compared
    with that of previous years, although clinics with good intentions may find it
    difficult to reduce their multiple birth rate, perhaps because patients are
    resistant to SET. Even if a clinic were doing nothing more than providing
    information to patients, there would be no enforcement measures available to
    Licence Committees (LCs) because there would be no breach of the Code.

Impact upon patients
4.9 Although many patients felt that they were adequately informed of the risks
    associated with multiple births and of their chance of conceiving twins,
    additional or improved information is unlikely to have a negative impact upon
    patients. A number of patients do feel that more information is needed, so they
    are likely to welcome Option 1 and not see it as having a positive affect on their
    experience of treatment.

Regulatory burden
4.10 The information requirements of Option 1, depending upon the detail, mean
     that clinics would be likely to need to update their patient information, in print
     and, where needed, online. However, this one-off burden on clinics could be
     lightened if HFEA were to publish sample information which clinics could tailor
     to their own use. If consent forms are to be updated, it would create some work
     in clinics to introduce the new forms into their processes, though this would be
     a one-off burden.




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Summary
 1: HFEA to work with clinics, patients and professional bodies to increase awareness of the
 risks of multiple births and to encourage increased use of single embryo transfer
                 Advantages                                  Disadvantages
 Feasibility     May change current practice,                May do little to change current
                 particularly if HFEA quick to remove        practice, so multiple birth rates would
                 some obstacles                              be unlikely to fall significantly
 Acceptability   The most acceptable to stakeholders:
                 especially patients, but also to
                 practitioners
 Practicality    Could use outcome data to detect            No ability to act against clinics with
                 clinics with a high twin rate               high twin rates, unless patient
                 Unproblematic to check patient              information was unsatisfactory
                 literature and consent forms.               Difficult to establish if patient
                 Unproblematic enforcement and               information is being used effectively
                 sanctions through LCs.
 Impact upon     Better information, both from clinics and
 patients        the HFEA, would increase awareness
                 and enable patients to make informed
                 decisions
 Regulatory      Relatively light compared to other          Need to produce updated patient
 burden          options, particularly if HFEA were to       information would impose a one-off
                 produce sample patient information          cost on clinics




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5    Option 2: HFEA to set a maximum twin rate of no more than 10 per cent
     that clinics must not exceed

5.1 Option 2 was suggested by the Expert Group as a way of requiring clinics to
    reduce their multiple births rates but of giving them the freedom to decide how
    to achieve this. Through this policy, clinics would need to set their own patient
    selection criteria for single embryo transfer and to account for the success or
    failure of their approach by reference to their multiple birth rate. The 10%
    maximum multiple birth rate could be phased in over a period of three years
    (20% in the first year, 15% in the second etc.).

5.2 By taking this approach, HFEA would be putting the onus on clinics to come up
    with their own solution to the high incidence of multiple births following IVF
    whilst itself steering clear of the difficult task of laying down robust, evidence-
    based patient selection criteria in HFEA guidance.

Feasibility
5.3 Experience from other countries suggests that clinics which apply SET to good
     prognosis patients can achieve a multiple pregnancy rate of around 10%.
     However, maintaining live birth rates would require, in many patients, the
     subsequent transfer of frozen-thawed embryos to those women who did not
     conceive on the fresh part of the cycle.

Acceptability
5.4 Option 2 was the least popular of all the options presented to stakeholders.
    Practitioners were concerned about how compliance would be measured and
    were keen that the HFEA set a wide margin of error, particularly for small
    clinics. Patients were concerned that clinics failing to come in under the
    maximum rate would insist that unsuitable patients have single embryo transfer,
    thereby not acting in their best clinical interests.

Practicality
5.5 Regulation Committee felt that this option would be very difficult to implement
     and enforce. One concern raised by the committee and by some of the
     stakeholders is the difficulty of setting statistically reliable maximum multiple
     births rates for clinics. For instance, if a clinic were performing fewer than 100
     cycles each year, it would need to be given a target range, say from 5 to 15%,
     in order to avoid being penalised for pure bad luck.

5.6 Another issue relates to breaches. With the guidance approach in Option 3, it
    would be clear, just as it is now, which cycles involve a breach of the Code. If
    Option 2 were adopted, inspectors may need to examine all patient records in
    order to determine whether a clinic which had exceed the maximum rate had
    acted unreasonably or not. Option 2 may result in significantly more work for
    clinics, inspectors and Licence Committees in cases where the maximum rate
    were exceeded.

5.7 Regulation Committee pointed out that pregnancy rates, rather than live birth
    rates, would need to form the basis of the assessment if we are to avoid
    compliance being based upon cycles data which is up to two years old.


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     Inspectors are increasingly using pregnancy rates on inspections, so this would
     not be a new approach.

Impact upon patients
5.8 If this policy option is to be effective, a significant proportion of women who
    currently have two embryos transferred during IVF would move to single
    embryo transfer with frozen follow-on cycles. This would mean an increase in
    the cost of treatment for the average private patient (though some would
    conceive on the first cycle and would therefore pay no more) and an increase in
    the time it takes to get pregnant for many patients.

5.9 For NHS-funded patients who receive funding for a full cycle (perhaps 40% of
    NHS-funded patients), there would be an increase in the time it takes to get
    pregnant for many patients. For those who receive NHS funding, but only for
    the fresh part of the cycle, the live birth rate would be reduced, unless patients
    could find their own resources for the storage and frozen embryo transfers, in
    which case there would be a cost burden that they had not anticipated.

5.10 Given the lack of support for this option amongst patients, its adoption may
     have a negative impact upon their experience of treatment, at least in the early
     stages. Even if clinics are able to provide the most appropriate treatment for
     each patient, the fact that many patients fear the emergence of a target
     mentality in clinics suggests that they may feel suspicious of their doctor’s
     advice.

5.11 However, Option 2 allows for more clinical discretion and flexibility than Option
     3, something which patients value. They may therefore feel that there is some
     room for discussion between doctor and patient and, as a result, fears about
     target mentality may lessen. This experience may vary from clinic to clinic,
     depending upon how strictly a clinic applies its criteria.

Regulatory burden
5.12 Option 2 would require clinics to draw up their own patient selection criteria. In
     order to do this, clinics would need to audit their own practice and review the
     literature to identify patients most suitable for SET. This may take some time
     and resources and could have a significant impact upon smaller clinics.

5.13 Monitoring of clinics’ adherence to the maximum rate and assessment of
     whether failure to comply is reasonable or not is also likely to take time both for
     clinics and the HFEA.




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Summary
 2: HFEA to set a maximum twin rate of no more than 10 percent that clinics must not exceed
                 Advantages                                 Disadvantages
 Feasibility     This approach would reduce multiple
                 birth rates and, as long as FETs were
                 used, maintain live birth rates
 Acceptability                                              Very low acceptance amongst
                                                            stakeholders, particularly patients
 Practicality    Maximum pregnancy rate easy to             Need to develop margins of error for
                 check, assuming that a wide margin of      the maximum twin rate, so that smaller
                 error for small clinics is used            clinics are not penalised unfairly
                                                            Significant HFEA time may be needed
                                                            to deciding on the whether a breach is
                                                            reasonable or not
 Impact upon     Patients potentially more able to          Increased use of SET would cost
 patients        influence clinical decisions and benefit   private patients more and would
                 from more flexibility                      reduce success rates for NHS patients
                                                            without full cycle funding
                                                            All patients having SET are likely to
                                                            need more treatment in order to
                                                            conceive
                                                            May have negative impact upon
                                                            patients’ experience if ‘target
                                                            mentality’ is feared
 Regulatory                                                 Some set-up costs associated with
 burden                                                     auditing and determining selection
                                                            criteria
                                                            Potential for time and resources
                                                            burden on clinics and HFEA when
                                                            maximum rate is exceeded




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6    Option 3: HFEA to set single embryo transfer patient selection criteria

6.1 This option takes perhaps a more traditional approach to multiple births: laying
    down in Code of Practice guidance which women should have single embryo
    transfer and which may have more. However, the guidance required for single
    embryo transfer needs to refer to more factors than the age of the female
    patient alone.

Feasibility
6.2 The Expert Group report suggested that guidance on single embryo transfer
     could refer to the female patient’s age, the number and quality of embryos
     created and whether she has had previous unsuccessful treatment. Assuming
     that the criteria were appropriate (they could be developed with professional
     organisations and clinic representatives), this would be an effective way of
     reducing multiple birth rates across the whole sector.

Acceptability
6.3 This was the second most popular option after Option 1 and tended to be
    favoured more by practitioners than by patients. Patients tended to be
    concerned about a restrictive approach: they were unconvinced that it would be
    sensitive enough not to disadvantage some patients and did not like the
    prospect of having the decision about the numbers of embryos transferred to be
    made by the HFEA on their behalf.

6.4 Of the different stakeholder groups, practitioners were most supportive of this
    approach. They felt that Option 1 was likely to be ineffective and, although they
    preferred to maintain clinical freedom, liked the ‘level playing field’ aspect of
    Option 3.

Practicality
6.5 Regulation Committee considered this option to be relatively straight forward to
     inspect against and enforce in most respects. Patient age, treatment history
     and embryo number would be easy to check on patient records (although
     having three criteria instead of the current one would be more work for
     inspectors). However, embryo quality is not something that can be enforced. If
     the guidance included reference to ‘good quality embryos’, clinics would need
     to adhere to their own embryo grading criteria (which is not uniform across all
     clinics) and inspectors could spot check patient records to see whether clinics
     have indeed transferred just one good quality embryo to women meeting the
     other selection criteria. But it would be impossible to check whether an
     embryologist had made an appropriate assessment of the quality of an embryo.

6.6 One way of minimising work for clinics and the HFEA would be to use the risk
    assessment tool to identify those clinics with a relatively high multiple birth rate.
    At inspection, there could be discussion about the possible reasons for this
    and, if necessary, spot checks on patient records to see if the selection criteria
    were being applied and the clinic was using its own embryo grading system. It
    would not be practical to require clinics to have a two-embryo transfer log, as
    currently required for three-embryo transfers, as the volume of cycles involving
    the transfer of two embryos would be too large to warrant this.


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Impact upon patients
6.7 The impact that this policy would have upon patients is much the same as that
    of Option 2. With a significantly higher proportion of single embryo transfers the
    cost of treatment for private patients would increase as more frozen embryo
    transfers would be needed. For those who receive NHS funding, but only for
    the fresh part of the cycle, the live birth rate would be reduced, unless patients
    could find their own resources for the storage and FETs, in which case there
    would be a cost burden that they had not anticipated. With increased use of
    frozen embryo transfers, many patients would have more treatment before they
    get pregnant.

6.8 There was little patient support for this policy approach, with many patients
    arguing that the decision about embryo transfer should be theirs. If this
    approach were taken, many patients may feel a lack of control over their
    treatment, at least in the early stages of implementation. On the other hand,
    patients may see the benefits of this approach, as it creates the most
    consistency of all the options.

Regulatory burden
6.9 The regulatory burden for this option would be lighter than for Option 3, as
    clinics would not need to develop their own patient selection criteria. This would
    particularly advantage smaller clinics which often lack the resources to work up
    their own selection criteria.




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Summary
 3: HFEA to set single embryo transfer patient selection criteria
                 Advantages                                     Disadvantages
 Feasibility     This approach would reduce multiple
                 birth rates and, as long as FETs were
                 used, maintain live birth rates
 Acceptability   Although it was not the most popular           Patients feel unhappy about the HFEA
                 option, practitioners welcomed the             making decisions which they feel
                 clarity and uniformity of this approach        should be their own to make
 Practicality    Could check for twin birth rates over a        Impossible to check compliance with
                 particular rate to identify potentially non-   the embryo quality criterion
                 compliant clinics
                 Unproblematic to check compliance on
                 all criteria except embryo quality
 Impact upon     Patients may come to see the benefit of        Increased use of SET would cost
 patients        an approach which creates uniformity           private patients more and would
                 across all clinics                             reduce success rates for NHS patients
                                                                without full cycle funding
                                                                All patients having SET are likely to
                                                                need more treatment in order to
                                                                conceive
                                                                Patients may feel a lack of control over
                                                                their treatment
 Regulatory      Lighter burden than for Option 2, as
 burden          clinics not required to work up their own
                 patient selection criteria




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7    Option 4: HFEA to set a maximum twin rate, but to impose single embryo
     transfer patient selection criteria on non-compliant clinics

7.1 This option was included in the consultation document as an amalgam of
    options 2 and 3 with the intention of overcoming some of their potential
    difficulties.

Feasibility
7.2 Option 4 has the same feasibility as Option 2. Experience from other countries
     suggests that clinics which apply SET to good prognosis patients can achieve a
     multiple pregnancy rate of around 10%. However, maintaining live birth rates
     would require, in many patients, the subsequent transfer of frozen-thawed
     embryos to those women who did not conceive on the fresh part of the cycle.

Acceptability
7.3 This Option was the third most popular of the four presented, though it attracted
    significantly more support than Option 2. Practitioners were slightly more likely
    to favour this option.

Practicality
7.4 Regulation Committee felt that this option contained many of the shortcomings
     of Options 2 and 3 and added little to their advantages. One further
     disadvantage was the burden upon inspectors and Licence Committees if they
     were regulating clinics which were effectively working to different guidance:
     most working on the maximum twin rate approach and a few having had patient
     selection criteria imposed by the HFEA.

Impact upon patients
7.5 As with Option 2, a significant proportion of women who currently have two
    embryos transferred during IVF would move to single embryo transfer with
    frozen follow-on cycles if this approach is adopted. This would mean an
    increase in the cost of treatment for the average private patient (though some
    would conceive on the first cycle and would therefore pay no more) and an
    increase in the time it takes to get pregnant for many patients.

7.6 For NHS-funded patients who receive funding for a full cycle (perhaps 40% of
    NHS-funded patients), there would be an increase in the time it takes to get
    pregnant for many patients. For those who receive NHS funding, but only for
    the fresh part of the cycle, the live birth rate would be reduced, unless patients
    could find their own resources for the storage and FETs, in which case there
    would be a cost burden that they had not anticipated.

7.7 Given the lack of support for the target approach amongst patients, its adoption
    may have a negative impact upon their experience of treatment, at least in the
    early stages. Even if clinics were able to provide the most appropriate treatment
    for each patient, the fact that many patients fear the emergence of a target
    mentality in clinics suggests that they may feel suspicious of their doctor’s
    advice.




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7.8 However, Option 2 allows for more clinical discretion and flexibility than Option
    3, something which patients value. They may therefore feel that there is some
    room for discussion between doctor and patient and, as a result, fears about
    target mentality may lessen.

Regulatory burden
7.9 As with Option 2, this option would require clinics to draw up their own patient
    selection criteria. In order to do this, clinics would need to audit their own
    practice and review the literature to identify patients most suitable for SET. This
    may take some time and resources and could have a significant impact upon
    smaller clinics.

7.10 Monitoring of clinics’ adherence to the maximum rate and assessment of
     whether failure to comply is reasonable or not is also likely to take time both for
     clinics and the HFEA.




TRIM: 07/12228                                                           Section D: 39
                                                                           HFEA (17/10/07) 401


Summary
 4: HFEA to set a maximum twin rate, but to impose single embryo transfer patient selection
 criteria on non-compliant clinics
                 Advantages                                 Disadvantages
 Feasibility     This approach would reduce multiple
                 birth rates and, as long as FETs were
                 used, maintain live birth rates
 Acceptability                                              Low acceptance amongst
                                                            stakeholders, particularly patients
 Practicality    As Option 2, the maximum pregnancy         Need to develop margins of error for
                 rate would be easy to check, assuming      the maximum twin rate, so that smaller
                 that a wide margin of error for small      clinics are not penalised unfairly
                 clinics is used                            Significant HFEA time may be needed
                 For non-compliant clinics, which will      to deciding on the whether a breach is
                 have SET patient selection criteria        reasonable or not
                 imposed, all criteria except embryo        Non-compliant clinics would be subject
                 quality would be unproblematic to          to different SET policies (option 2 for
                 enforce                                    compliant clinics, option 3 for the rest),
                                                            which may cause problems for
                                                            Regulation. For those clinics, it would
                                                            not be possible to check compliance
                                                            with the embryo quality criterion
 Impact upon     Patients potentially more able to          Increased use of SET would cost
 patients        influence clinical decisions and benefit   private patients more and would
                 from more flexibility                      reduce success rates for NHS patients
                                                            without full cycle funding
                                                            All patients having SET are likely to
                                                            need more treatment in order to
                                                            conceive
                                                            May have negative impact upon
                                                            patients’ experience if ‘target
                                                            mentality’ is feared
 Regulatory                                                 Some set-up costs associated with
 burden                                                     auditing and determining selection
                                                            criteria
                                                            Potential for time and resources
                                                            burden on clinics and HFEA when
                                                            maximum rate is exceeded




TRIM: 07/12228                                                                      Section D: 40
                                                                 HFEA (17/10/07) 401


8    Option 5: HFEA to require clinics to develop their own patient selection
     criteria for single embryo transfer and to monitor each clinic’s multiple
     birth rate

8.1 This policy option was added to the four included in the consultation document,
    following discussion on the practicality of the four options at Regulation
    Committee meetings in July and September. Bearing in the mind the practical
    difficulties associated with Options 2, 3 and 4, the committee suggested the
    addition of an option which borrowed the approach of Option 2 whilst seeking to
    minimise its disadvantages.

8.2 Taking this approach would, as with Option 2, give clinics the freedom to
    develop their own patient selection criteria rather than have criteria imposed
    upon them. However, by adopting this policy, the HFEA would not seek to
    enforce a maximum multiple pregnancy rate, but would instead monitor clinics’
    rates and seek to work with them to bring those rates down.

8.3 This policy could include a commitment by the HFEA to create opportunities,
    perhaps in collaboration with the professional bodies, for clinics to share good
    practice and experience of success in relation to single embryo transfer.

Feasibility
8.4 As with Option 1, the effectiveness of this policy depends upon the action that
     clinics take to address multiple births. Some may develop very tight patient
     selection criteria, thereby reducing multiple pregnancy rates only slightly.
     However, others may develop broader criteria to mirror that of Option 3. It is
     likely, therefore, that multiple pregnancy rates will reduce a little, but by no
     means as much as they would if Options 2, 3 or 4 were adopted.

Acceptability
8.5 Since Option 5 was not part of the consultation, we have no information about
    stakeholder attitudes towards it. However, one downside of this option which
    was voiced by stakeholders in relation to Option 1 was that it would create
    inconsistency between clinics and may create uncertainty amongst patients.

Practicality
8.6 This approach would have similar practical issues to those of Option 1. The
     only requirement would be for clinics to have patient selection criteria and to
     use them accordingly. It would not be for the HFEA to decide whether the
     criteria were reasonable or not.

8.7 However, it would be nonsensical to introduce a policy but to take no interest in
    its effectiveness. A monitoring process would therefore be needed (possibly a
    Policy/Regulation collaboration) to assess effectiveness and to identify clinics
    which are doing little to reduce their multiple pregnancy rate. Although no
    regulatory action could be taken against those clinics, HFEA could use the
    inspection process to discuss good practice and encourage clinics to learn from
    successes in other clinics.




TRIM: 07/12228                                                          Section D: 41
                                                                  HFEA (17/10/07) 401


Impact upon patients
8.8 For patients attending clinics which have adopted selection criteria similar to
    those of Option 3, this option would have a similar impact upon the cost of
    treatment, the chance of conceiving and the length of time needed to get
    pregnant. For clinics which develop more narrow criteria, these impacts would
    be less significant.

8.9 Patients may find that the variation between clinics that is likely to develop
    (though this variation already exists to a degree) makes it more complicated to
    choose a clinic in the first place. Others, however, may welcome the variation
    and the ability to choose a clinic which shares their attitude towards single
    embryo transfer.

Regulatory burden
8.10 To draw up patient selection criteria, clinics would need to audit their own
     practice and review the literature to identify patients most suitable for SET. This
     may have resource implications, particularly for smaller clinics.




TRIM: 07/12228                                                          Section D: 42
                                                                            HFEA (17/10/07) 401


Summary
 5: HFEA to require clinics to develop their own patient selection criteria for single embryo
 transfer and to monitor each clinic’s multiple birth rate
                 Advantages                                  Disadvantages
 Feasibility     May do more than Option 1 to                May do little to change current
                 encourage increased used of SET             practice, so multiple birth rates are
                                                             unlikely to fall significantly
 Acceptability   No data on stakeholder views
 Practicality    Easy to check that clinics have selection   No ability to act against clinics with
                 criteria and that they are using them       high twin rates, as long as they have
                                                             patient selection criteria
 Impact upon     Patients may welcome the ability to         Patients attending clinics with broad
 patients        choose between clinics according to         criteria may pay more for treatment,
                 their single embryo transfer selection      see lower success rates (if NHS
                 criteria                                    patients with partial funding) and wait
                                                             longer to get pregnant
                                                             Patients may be confused by the
                                                             inevitable variation in criteria
 Regulatory                                                  Some set-up costs associated with
 burden                                                      auditing and determining selection
                                                             criteria




TRIM: 07/12228                                                                       Section D: 43
                                                          HFEA (17/10/07) 401 – ANNEX A


Section E: Annexes
Annex A: Evidence from the written consultation
Question 1: What is your interest in multiple births after IVF?
(Respondents could tick more than one box).



829 people responded to the consultation, the majority of which were patients. Only
one response was received from the Neonatologist/Paediatrician group. This
response has therefore been included under ‘Other’.


                    2%
                2%             2%
                         7%
               1%
            1%
           1%                                                     Patient
          3%                                                      Fertility doctor
                                                                  Embryologist
                                                                  Fertility nurse
                                                                  Counsellor
                                                                  NHS
                                                                  Non-patient parent
                                                                  Other
                                                                  Organisation


                                               81%




TRIM: 07/12228                                                                      Section E: 44
                                                               HFEA (17/10/07) 401 – ANNEX A


Question 2: Do you think there is too much or not enough emphasis on the health risks for
twins and their mothers?



Summary of all responses (804)




                                16%




                                                                   The right degree of emphasis
                                                                   Too much emphasis

                          24%                                      Not enough emphasis
                                                     60%




Summary of how each group responded

                 100

                     90

                     80

                     70

                     60
                                                                       Not enough emphasis
      %




                     50                                                The right degree of emphasis
                                                                       Too much emphasis
                     40

                     30

                     20

                     10

                      0
                                                      er
                                               S
                                              e
                                     yo p

                                  lit ist




                                               r




                                                               n
                                   nt p




                                             nt
                                             H
                                            lo
                                             u




                              C urs




                                                    th

                                                             io
                                           u

                                         ro

                                          g




                                         re
                                         N
                                         el
                                        ro




                                                           at
                                                   O
                                       lo

                                       N
                                       G




                                      pa
                                      ns
                                      G




                                                       is
                                     y




                                                     an
                                 ou
                an




                                 nt
                                br
                               ie




                                                    rg
                              rti




                             tie
                             m
                 i

                            at
              ic




                          Fe




                                                   O
                           E




                          pa
          lin

                     P
          C




                       on
                     N




The chart above shows how each group of respondents answered Question 2. While
the majority of the NHS group, Counsellor group, and Embryologist group all


TRIM: 07/12228                                                                           Section E: 45
                                                     HFEA (17/10/07) 401 – ANNEX A


indicated that there was not enough emphasis on the health risks of twins, most
other groups felt that there is the right degree of emphasis. Patients overwhelmingly
considered that there is the right degree of emphasis on the risk. Given that this is
the largest group of respondents, the cumulative results also reflect this option.

Patient group (patients, those waiting for treatment, those who have had treatment
and partners of patients) responses to Question 2 (708)



                                         11%

                     24%




                                                          Not enough emphasis
                                                          The right degree of emphasis
                                                          Too much emphasis




                                          65%




Professional group (fertility doctors, fertility nurses, embryologists and counsellors)
responses to Question 2 (56)



                           18%




                                                    43%
                                                                 Not enough emphasis
                                                                 The right degree of emphasis
                                                                 Too much emphasis




                      39%




When comparing the responses of the professional group with the patient group, it is
apparent that a larger proportion of the professional group considered that there is
not enough emphasis placed on the risks of having twins. A significant proportion of
both groups considered that there is too much emphasis placed on the risks.




TRIM: 07/12228                                                                     Section E: 46
                                                HFEA (17/10/07) 401 – ANNEX A


Reasons for choosing ‘Not enough emphasis’ (76) were:


       100


        80


        60
  %

        40


        20


         0
                 1       2          4           5             6




Reasons for choosing ‘Too much emphasis’ (99) were:



       100


        80


        60
  %

        40


        20


         0
                 1       2           3           4                6



Reasons for choosing ‘Right degree of emphasis’ (233) were:




        100


         80


         60
   %

         40


         20


             0
                 1   2          3         4          5            6




TRIM: 07/12228                                                        Section E: 47
                                                   HFEA (17/10/07) 401 – ANNEX A


Key
1. Patients have enough information on multiple birth risks to make an informed
   decision about embryo transfer.
2. All pregnancies have risks, whether IVF or non-IVF
3. The risk of twins is overstated and therefore the emphasis is unnecessary
4. The primary patient concern is the risk of not getting pregnant and therefore
   multiple birth risks are small in comparison
5. The risks associated with multiple births cannot be ignored and therefore the
   current level of patient information is justified or more information may be
   beneficial
6. Other




TRIM: 07/12228                                                         Section E: 48
                                                              HFEA (17/10/07) 401 – ANNEX A


Question 3: Who do you think should decide which women should have just one embryo
transferred during IVF?
1. The HFEA through guidance to fertility centres
2. Professional bodies (organisations that represent fertility practitioners) through recommendations to
fertility practitioners
3. Only the clinician in discussions with the patient
4. Other



Summary of all responses (779)



                                                                      Only the clinician in discussions
                            12%                                       with the patient


                       4%

                                                                      The HFEA through guidance to
                  6%                                                  fertility centres




                                                                      Professional bodies through
                                                                      recommendations to fertility
                                                                      practitioners



                                                                      Other


                                                  78%




Summary of how each group responded

           100.0

             90.0
                                                                    Only the clinician in
             80.0                                                   discussions with the patient
             70.0
                                                                    Professional bodies
             60.0
   %




             50.0
                                                                    The HFEA through guidance
             40.0
                                                                    to fertility centres
             30.0
                                                                    Other
             20.0

             10.0

              0.0
                           an er
                           nt HS
                                         e
                          br oup

                                        st




                                          r




                                         n
                            nt p




                                        nt
                                       lo
                        C urs




                        rg Ot h

                                      io
                                      u



                        rti ogi




                                    re
                                    N
                      at gro




                                    el




                                   at
                                    r



                                 N
                                 G




                                ns




                               pa
                                  l




                                is
                              yo

                               y
                           an




                           ou
                           lit
                         ie
              i




                        ie
                      m
           ic




                    Fe




                     O
                     at
       lin




                    E
                  P




                  -p
       C




               on
             N




TRIM: 07/12228                                                                            Section E: 49
                                                     HFEA (17/10/07) 401 – ANNEX A


The chart above shows that in most groups the majority of respondents considered
that only the clinician in discussions with the patient should determine whether a
single embryo is transferred in IVF. The Neonatologist/Paediatrician response
reflects that of one individual.

Patient group responses (685)



                       11%

           3%

         3%
                                                  Only the clinician in
                                                  discussions with the patient
                                                  Professional bodies

                                                  The HFEA through guidance to
                                                  fertility centres
                                                  Other




                                    83%




Professional group responses (53)




                  17%



                                                   Only the clinician in
                                                   discussions with the patient
                                                   Professional bodies

        17%                                        The HFEA through guidance to
                                            55%    fertility centres
                                                   Other




                 11%




It is apparent from these graphs that the overwhelming majority of the patient group
considered that only the clinician in discussions with the patient should decide who
should have a single embryo transferred. In comparison to the patient group, a



TRIM: 07/12228                                                                   Section E: 50
                                                      HFEA (17/10/07) 401 – ANNEX A


greater proportion of the professional group thought that the HFEA through guidance
to fertility centres or professional bodies should play a role in determine which
patients receive a single embryo.

Reasons provided for choice of option:

Reasons provided for ‘Only the Clinician in discussions with the patient’ were: (435)



     100



      80



      60
 %


      40



      20



       0
           1            2            3            4              5




Reasons given for ‘Professional bodies’ were: (30)



     100


     80


     60
 %


     40


     20


      0
               1                    4                        5




TRIM: 07/12228                                                         Section E: 51
                                                   HFEA (17/10/07) 401 – ANNEX A


Reasons for the answer ‘HFEA through guidance to fertility centres’ were: (46)


       100



        80



        60
  %


        40



        20



            0
                    1          3               4                5




Key
1. The decision should be made on a case by case basis between patient and
   doctor because each case is different
2. The decision should ultimately be the patients’. Patients undergo the emotional
   turmoil of IVF and fund treatment. They can make a decision after consulting
   doctors
3. There is already too much interference by the HFEA/Government
4. Patients need to be protected by an impartial body or some guidelines are
   needed
5. Other
There were a number of respondents that indicated that decision-making should be
performed by someone else other than those options provided. The reasons for this
choice are outlined in the graph below, indicating that some respondents strongly felt
that the ultimate decision should be that of the patient (94).



      100



       80



       60
 %


       40



       20



        0
                1          2               3               4                5




TRIM: 07/12228                                                         Section E: 52
                                                       HFEA (17/10/07) 401 – ANNEX A


Question 4: Do you think the current guidance on embryo transfer by the HFEA is about right?
1. Yes, it is essentially okay
2. No, it is too strict and limits the women’s chances to conceive
3. No, it is not strict enough and allows the high number of twin pregnancies to continue



Summary of all responses (778)



                        8%


                                                        Yes, it is essentially okay




            30%
                                                        No, it is too strict and limits
                                                        w omen’s chances to conceive


                                               62%
                                                        No, it is not strict enough and
                                                        allow s the high number of tw in
                                                        pregnancies to continue




Summary of how each group responded

        80


        70
                                                          Yes, it is essentially okay
        60


        50                                                No, it is not strict enough and allow s
                                                          the high number of tw in
                                                          pregnancies to continue
    %




        40

                                                          No, it is too strict and limits w omen’s
        30                                                chances to conceive

        20


        10


            0
                                   S
                     ity st
             F yo t
                                  n




                       ni r
                                   r
                     ou e




                                  n
                                 nt
                    br en




                                 e
                                lo

                 i e NH
                                ia




                             tio
                 C urs
                  til gi




                rg th
                            re
                            el
                           ic


                              i
               er lo
                          at




                         sa
              O O
                        pa
                        lin




                        ns
                         N
                        P
        C




                     nt




                     a
                m




              at
              E




            -p
          on
        N




TRIM: 07/12228                                                                    Section E: 53
                                                   HFEA (17/10/07) 401 – ANNEX A


The above chart shows that except for the NHS group, Organisations, and the
Neonatologist/Paediatrician respondent, most other groups considered that the
current HFEA guidance on embryo transfer is essentially okay. The Counsellor group
responses were evenly distributed across the options.

Patient group responses (686)




   32%
                                                   Yes, it is essentially okay



                                                   No, it is not strict enough and
                                                   allows the high number of
                                                   twin pregnancies to continue
                                                   No, it is too strict and limits
                                                   women’s chances to conceive

                                     65%
   3%




Professional group responses (50)



          18%




                                                  Yes, it is essentially okay


                                                  No, it is not strict enough and
                                                  allows the high number of
                                                  twin pregnancies to continue

                                           58%    No, it is too strict and limits
  24%                                             women’s chances to conceive




A greater proportion of the professional group, in comparison to the patient group,
considered that the current guidance on embryo transfer is not strict enough. A large
proportion of the patient group, in comparison to that of the professional group,
thought that current guidance is too strict.


TRIM: 07/12228                                                                      Section E: 54
                                                             HFEA (17/10/07) 401 – ANNEX A


Question 5: Part 4 of this document contains regulatory options for the HFEA – which one do
you prefer?
Option 1: HFEA to work with clinics, patients and professional bodies to encourage increased use of
single embryo transfer.
Option 2: HFEA to set a maximum twin rate for fertility centres
Option 3: HFEA to develop new guidance for the Code of Practice that defines which group of
patients should only be offered one embryo per transfer
Option 4: A combination of 2 and 3 above, ie. Clinics could be given an overall set maximum twin birth
rate. If they fail to achieve it or don’t seem to try, they have more detailed guidance imposed on them
by HFEA.
Option 5: None of the above



Summary of responses: (759)


                                               24%


                                                               Option 1
                                                               Option 2
          45%
                                                               Option 3
                                                     3%
                                                               Option 4

                                                               Other

                                                 16%



                                 12%




TRIM: 07/12228                                                                       Section E: 55
                                                                                                HFEA (17/10/07) 401 – ANNEX A


Summary of how each group responded


        50

        45

        40

        35
                                                                                                                                      Option 1
        30
                                                                                                                                      Option 2
    %




        25                                                                                                                            Option 3
                                                                                                                                      Option 4
        20
                                                                                                                                      Option 5
        15

        10

        5

        0
                                                                                                   S
                               ient
                       n




                                                                                                          er
                                             gis t


                                                                e


                                                                         or




                                                                                                                          ion
                                                                                                  t
                                                                                                NH


                                                                                               ren
                  ic ia




                                                             s




                                                                                                       Oth
                                                                           ll
                                                         Nu r


                                                                       ns e




                                                                                                                      s at
                           Pat


                                             olo




                                                                                           t pa
             Cli n




                                                                                                                  a ni
                                         bry


                                                      tili ty


                                                                    Cou




                                                                                      ti en




                                                                                                               Org
                                      Em


                                                     Fer




                                                                                   -pa
                                                                                Non




Because of the large number of responses that chose Option 5, and then went on to
state that the Status Quo should continue to apply, the response data to this
question can be reallocated to look like: (759)



                                                   5%

                                                                                24%




                                                                                                                         Option 1
                                                                                                                         Option 2
                                                                                                                         Option 3
               40%                                                                         3%
                                                                                                                         Option 4
                                                                                                                         Status Quo
                                                                                                                         Other

                                                                                     16%




                                                                12%




TRIM: 07/12228                                                                                                                      Section E: 56
                                                       HFEA (17/10/07) 401 – ANNEX A


Patient group responses (664)



                            2%

                                           23%




                                                                 Option 1
                                                                 Option 2

                                                   3%            Option 3
         46%
                                                                 Option 4
                                                                 Status Quo
                                                                 Other

                                                 15%




                                    11%




Professional group responses (55)



                           6%


                 17%
                                                 29%


                                                                         Option 1
                                                                         Option 2
                                                                         Option 3
                                                                         Option 4
                                                                         Status Quo
            17%                                                          Other
                                                   6%




                                  25%




Similar proportions of the patient and professional groups chose Option 1. A greater
proportion of the patient group however chose Option 5 (none of the above). A




TRIM: 07/12228                                                              Section E: 57
                                                       HFEA (17/10/07) 401 – ANNEX A


slightly larger proportion of the professional group chose Options 3 and 4, with
Option 2 being the least preferred option in both groups.

Reasons provided for choice of option:

Those that chose Option 1 gave the following reasons for their answer: (111)



     100



     80



     60
 %




     40



     20



      0
               1       2       3       4       5        6




Those that chose Option 2 gave the following reasons for their answer: (10).



      100



       80



       60
 %




       40



       20



           0
                   1       2       3       4       5        6




TRIM: 07/12228                                                         Section E: 58
                                                    HFEA (17/10/07) 401 – ANNEX A


Reasons for choosing Option 3 were as follows: (54)



     100



     80



     60
 %




     40



     20



      0
               1           2       3       5           6




The high proportion of respondents indicating that decision-making should be on a
case by case basis may indicate that the question did not clearly make a distinction
between HFEA Guidance and guidelines. The written responses indicate that those
in support of this option largely anticipated that the HFEA would issue guidelines that
would assist decision-making, rather than require clinics to make decisions in a
certain way against criteria.

Those that chose Option 4 gave the following reasons for their decision: (39)



      100


       80


       60
 %




       40


       20


           0
                   1   2       3       4       5           6




Similarly to those who chose Option 3, the number of respondents stating that
decision-making should be on a case by case basis may indicate that the nature of
Option 4 was not clear.

The most popular option under Question 5 was not however an option from 1 to 4.
Most chose ‘Other’ and then gave reasons for this choice. The reasons for this



TRIM: 07/12228                                                          Section E: 59
                                                       HFEA (17/10/07) 401 – ANNEX A


choice are outlined in the graph below, and indicate that many respondents did not
consider any HFEA intervention to be warranted to reduce the number of multiple
births. (315)

Key
1. Decision-making should be done on a case by case basis or be up to the patient
   (in consultation with their doctor).
2. There should be no regulation because of the lack of NHS funding for treatment
   and the expense for patients.
3. SET should not be imposed because it will impact on success rates/DET has
   greater success rate.
4. The current situation is fine.
5. There is already too much regulation.
6. Other



      100


       80



       60



       40
  %




       20


        0
            1       2          3         4         5          6




Of interest is the policy option choice of respondents that considered that decision-
making should be between doctor and patient under Question 3 (Chart below) The
choice of Options 1 and 5 are consistent with their position that decision making
should be left to the doctor/patient. The relatively high number of respondents that
chose Options 2, 3 and 4 may indicate that the regulatory nature of these Options
was not clear.




TRIM: 07/12228                                                          Section E: 60
                                                            HFEA (17/10/07) 401 – ANNEX A


                     300



                     250



                     200
  No. of responses




                     150



                     100



                     50



                      0
                           Option 1   Option 2   Option 3         Option 4      Option 5




TRIM: 07/12228                                                               Section E: 61
                                                             HFEA (17/10/07) 401 – ANNEX A


Question 6: The Expert Group investigating the question of multiple births after IVF and the
HFEA have discussed some possible obstacles to change. Do you think that any of the factors
listed below make it harder to effectively reduce the proportion of twin pregnancies after IVF?
(Respondents could select more than one)
1. The lack and inconsistency of NHS funding for fertility treatments
2. The lack of understanding of the risks involved in multiple pregnancies by patients and/or fertility
practitioners
3. A desire for twin pregnancies by some patients and fertility practitioners
4. The way the HFEA produces and presents outcome data for fertility clinics (pregnancy rate per
fresh cycle started)
5. Competition between fertility centres
6. The absence of professional guidance on eSET (guidance developed by the relevant professional
bodies like ACE, the BFS and the RCOG)
7. Lack of UK data on eSET
8. Uncertainty whether the international experience with eSET can be applied in the UK
9. Lack of understanding of the issue by NHS commissioners
10. Inconsistency of embryo grading and selection between fertility clinics
11. Inconsistency or freezing protocols and problems with the availability of embryo freezing
12. Lack of follow-up of health outcomes for IVF children

Distribution of responses to Question 6 (239) (numbers refer to options proposed in
the question above)

     80


     70


     60


     50

 %
     40


     30


     20


     10


      0
          1      2      3       4      5       6      7       8       9      10      11     12        Other




The lack of NHS funds for IVF was considered by respondents to be the biggest
obstacle to moving towards SET. Lack of UK data was also a popular barrier.

Distribution of Patient Group Responses (214)

     80


     70


     60


     50

 %
     40


     30


     20


     10


      0
          1      2      3       4      5       6      7       8       9      10      11     12        Other




TRIM: 07/12228                                                                        Section E: 62
                                                                                                           HFEA (17/10/07) 401 – ANNEX A


Professional Group Responses (10)

     80


     70


     60


     50
 %




     40


     30


     20


     10


     0
               1           2             3            4          5            6              7             8          9           10         11       12           Other




A similar distribution of responses is seen across the professional and patient
groups, with greater emphasis placed on lack of funding and the lack of UK data.
Professionals did place more emphasis on ‘Competition between clinics, the way the
HFEA presents outcome data, the absence of guidance, inconsistency of freezing
protocols, and the lack of understanding of the risks of twins.

Respondents were asked to suggest other possible barriers to the implementation of
SET. These are outlined below: (Note that only true ‘other’ barriers are included in
this data set. Repetition of already identified barriers have been excluded). (97)

 40

 35

 30

 25

 20

 15

 10

     5

     0
             Patients will go     SET policy will reduce   Lack of overseas       Public distrust of the         Need for                Free              Other
          abroad for treatment.      success rates/        support for SET.              HFEA              research/advance in    choice/Resistance
                                   increase IVF cycles                                                             IVF              from patients
                                                                                                           treatments/Clinician
                                                                                                                  skills




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                                                         HFEA (17/10/07) 401 – ANNEX A


Question 7: Is there anything else you want to tell the HFEA about the issues raised in this
consultation document?

Respondents were given an opportunity to make any comment about multiple births
and single embryo transfer. These responses largely reiterated the points that had
been made in response to other questions. The data set below outlines in broad
terms what the focus of these responses were, noting that respondents were able to
identify a number of issues in response to this question. (397)

      25




      20




      15
  %




      10




      5




      0
           1     2       3       4       5       6       7       8       9       10      11




Key
1. Decision-making should be on a case by case basis. Patients are capable of
   making decisions. No regulation is required.
2. The lack of NHS funding for IVF and the private expense of IVF means that
   patients have a right to make a consumer decision about embryo transfer and
   multiple birth risks.
3. SET reduces the chance of success/success rates need to be improved through
   further research. Patients want the best possible chance to conceive and SET will
   reduce this chance.
4. Patients should be given more information on the risks of multiple births or some
   form of guidelines are needed. Not HFEA guidance, but flexible guidelines.
5. The SET proposal and the HFEA consultation does not take into account the
   personal stress and emotional aspects of IVF.
6. Patients will go abroad for treatment if SET is implemented.
7. The SET proposal represents a money saving initiative by government.
8. More information/UK data (and research) is required before a policy is decided
   upon. This includes research into how to improve success rates.
9. The current situation is fine as it is.
10. There is a need for some degree of regulation. Guidelines are needed to prevent
    clinics breaching Code of Practice and to protect patients.
11. Other


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                                                    HFEA (17/10/07) 401 – ANNEX B


Annex B: Evidence from the practitioner public meeting
The meeting was held on the 11 June 2007 at the Law Society, Chancery Lane,
London. The aim of the meeting was to find out about practice in individual clinics
and to ask delegates to think about what they can do, what are the obstacles to
reducing the incidence of multiple births and what should the HFEA do about
multiple births. The majority of the delegates were either fertility doctors,
embryologists, fertility nurses or counsellors.

Programme

The meeting started with a short introduction from Angela McNab, Chief Executive of
the HFEA, followed by two presentations from Yacoub Khalaf, Guy’s Assisted
Conception Unit, about the views of the professional bodies, and Clare Brown,
member of the Authority and Chair of Infertility Network UK, discussing the
regulatory options.

Plenary discussion

After the presentations the chair invited comments and questions from the delegates.
The following points were raised in discussion:

          One of the delegates requested further evidence of the risk of disability to
           a child, and stated that he was yet to be convinced of the risks to both
           babies born and the mother. However the majority of delegates felt that
           there was sufficient evidence of the increased risk of twins and multiples.
          That there is evidence to show that all IVF babies are disadvantaged
           when compared to non-IVF babies. They have lower birth rates and are
           more likely to be premature.
          Issue of multiple births from stimulated IUI and other non-IVF fertility
           treatments, and questioned whether or not this review should/does apply
           to stimulated IUI and other non-IVF fertility treatments.
          Sanctions for clinics that had a high multiple births rate would not be able
           to be applied immediately as it would take two years for the clinics results
           to become available.

Group discussion

The delegates were divided into four groups to discuss three specific questions:

          What can doctors, nurses and embryologists (and others) do to reduce
           the incidence of multiple births?
          What are the obstacles to achieving this?
          What should the HFEA do about multiple births?

Current practice in clinics
Delegates were asked to talk through the current practice in their clinics. The
discussion highlighted the fact that clinical practice varies between clinics. Some
centres do have a single embryo transfer policy in place and others do not, with
some centres only offering SET if a patient specifically requests it.




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                                                     HFEA (17/10/07) 401 – ANNEX B


The majority of clinics discuss the number of embryos to be transferred with patients
at the first appointment. These discussions are with the fertility doctor, the
embryologist or the nurse practitioner.

Centres offering blastocyst transfer tend to have single blastocyst transfer policies in
place – usually for women under 35 – as they recognise the high twin rates for this
treatment. One clinic has a specific consent form for patients having two blastocysts
transferred, in order to record that the patient understand the risks of double
blastocyst transfer.

The freezing protocols also differ considerably between clinics, with some centres
only freezing blastocysts.

Question 1: What can doctors, nurses and embryologists (and others) do to reduce
the incidence of multiple births?
The groups came up with a series of recommendations for action that clinics and
their staff could do to reduce the incidence of multiple births.

Professional consensus on embryo grading
There are no universal embryo grading standards, which mean that the criteria differ
between centres. The ESHRE model was suggested as a possible grading protocol.
It was also felt that there should be separate grading guidance for embryos and
blastocysts.

Patient selection criteria for single embryo transfer
Many centres do not have policies in place setting out criteria patients should fulfil to
be offered eSET.

Ensuring good understanding of the risks among patients and clinic staff
The risks of having twins needs to be balanced against the risk of not getting
pregnant at all. The small figures given as the risks mean that they are often not
seen as significant – for example of all the patients going for treatment it is possible
that only 7.5% of them will have twins and the (proportion) of these twins will not be
healthy is even smaller. There is also often a lack of understanding of exactly what
the risks mean in their particular situation.

Better patient information given throughout treatment
All discussion groups felt that better, simpler patient information was necessary and
pointed out that, for example, there may be little understanding of what having a
child with cerebral palsy actually means and so centres need to develop ways of
ensuring that patients understand the condition.

Information about embryo transfer and multiple pregnancies given by all
members of staff
All members of staff in clinics should be aware of the risks of multiple births and be
able to discuss these at all stages of treatment. It should also be part of the
implications counselling that patients receive.




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                                                      HFEA (17/10/07) 401 – ANNEX B


Clinics share information and best practice
There is very little communication between centres about best practice and it was
suggested that work shops or meetings to share best practice would be very
valuable.

Question 2: what are the obstacles to achieving this?
League tables
The majority of infertility treatment is in the private sector meaning that there are
business drivers. A lower success rate means that fewer patients will choose that
centre and centres doing more SET are likely to have lower overall success rates.
Delegates suggested presenting the data in a format that shows a successful
outcome as one of a healthy singleton birth.

Delegates find that the data is not presented in a very ‘user friendly’ manner making
it inaccessible for both clinic staff and patients. It was suggested that more ‘soft’
information should be presented to accompany the data.

Funding
Without NHS funded cycles of IVF delegates thought that it would be unlikely that
patients would support a move they perceived to reduce their success rates.

Delegates pointed out that the funding of treatment cannot ‘move’ from one
treatment to another i.e. tubal surgery referred for fertility treatment, which will mean
moving to the end of the waiting list.

Patient perception
Patient perception of twins is that they are a positive outcome of treatment. For some
patients having twins is preferable to having singletons as it completes their family in
one cycle of treatment.

Clinic staff perception
If clinic staff do not support the move to reduce the numbers of multiple births this
may prevent them from encouraging patients to have SET.

Underestimation of risk
Delegates felt that the risks of having twins are either not properly understood or not
properly communicated among both patients and clinic staff.

Lack of universal embryo grading system
Assessing embryo quality is very subjective which makes developing standards
difficult. If this is bought in as a criterion of assessing embryo quality it will be
impossible for the HFEA to assess.

Practicalities
Practical issues such as storing embryos separately, which would impact on the
space needed to store the embryos. There are also likely to be staffing issues as
centres move towards more blastocyst transfer because as the embryos are cultured
for longer it will necessitate weekend transfers.




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                                                        HFEA (17/10/07) 401 – ANNEX B


Question 3: What should the HFEA do about multiple births?
Definition of a cycle of IVF to be uniform across all funding bodies
A central statement from the Minister would ensure that all commissioners were
funding a full cycle of IVF as specified in the NICE guidelines.

Education for patients
The need for good, clear and simple information for patients that is not
scaremongering yet sets out the risks. The HFEA could produce information for all
clinics to present to their patients in collaboration with patient groups and
professional bodies.

Realistic implementation timetable
The HFEA needs to set a realistic implementation timetable for centres, allowing
them time to update patient information and brief staff. Clinics are also in the process
of implementing the changes resulting from the EU Tissues and Cells Directive.

Good patient information about the risks of fertility tourism
Delegates felt that it was really important for the HFEA to provide information about
the risks of fertility tourism as it is likely to increase if more restrictive embryo transfer
criteria are introduced.

Data presentation and success rates
The presentation of data in a way that will not discriminate against those centres
offering SET and in a way that can be easily understood by both patients and clinic
staff.

Blastocyst transfer analysis
It was suggested that when the data set is large enough the HFEA should analyse
the data from single blastocyst transfers.

Consultation options
The groups then went on to discuss the options set out in the consultation document.
Some of the groups discussed this in more detail than others due to time constraints.

Option 1: Three out of the four groups felt that option 1 was important and should
happen regardless of the outcome of the consultation. However the majority felt that
sanctions would be necessary to ensure that the multiple birth rate was lowered.

Option 2: There was concern about the implementation of option 2 and how the
maximum twin rates would be controlled. There were suggestions of best practice
work shops for clinics.

Option 3: Delegates felt that although this was the most enforceable option it also
allowed the least amount of flexibility for clinical discretion. There is a need for
simple workable criteria if this option were to be suggested.

Option 4: This option was found preferable by one group, who felt that the best
approach was a combination of options 2 and 3 as option 1 was unlikely to work.




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Summary of recommendations from the practitioners’ consultation meeting

Recommendations for clinics and their staff:
      Help to develop a professional consensus on embryo grading
      Develop their own patient selection criteria for single embryo transfer
      Ensure a good understanding of the risks among patients and clinic staff
      Better patient information given throughout treatment
      Information about embryo transfer and multiple pregnancy should be
       given by all members of staff
      Clinics should share information and best practice

Obstacles to increased use of single embryo transfer:
         ‘League tables’ which are not user-friendly and encourage competition
          between clinics
         Poor funding of IVF by the NHS
         Patient perceptions of twins as a desirable outcome
         Clinic staff perception that single embryo transfer is not advisable
         Underestimation of the risk of multiple births by patients and clinic staff
         Lack of a universal embryo grading system
         Practicalities of storing embryos singly
         Practicalities of increased use of blastocyst transfer (such as working
          hours)

Recommendations for HFEA action:
      Encourage the Department of Health to inform PCTs of the need to fund a
       full cycles of IVF treatment
      Produce information for patients on multiple births which does not scare-
       monger, yet clearly sets out the risks
      Produce information for patients about the risks of having treatment
       abroad
      Adopt a realistic implementation timetable
      Present outcome data in a way that will not discriminate against those
       centres offering SET and in a way that can be easily understood by both
       patients and clinic staff
      Analyse the blastocyst transfer cycles, when the dataset is large enough




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                                                    HFEA (17/10/07) 401 – ANNEX C


Annex C: Patient consultation meeting
The meeting was held on the 23 June 2007 in London. The aim of the meeting was
to find out about patient experiences of being given information about the risks of
multiple births, to ask what they thought could be done by the HFEA and clinics to
reduce the numbers of multiple births, and to discuss the policy options set out in the
HFEA consultation. This meeting had a very low turn-out, probably because patients
felt reluctant to attend a meeting organised by the HFEA on a topic about which they
felt concerned

Delegates

The patients that attended were a mix of those who had had undergone treatment
both successfully and unsuccessfully, and patients in the process of having
treatment. There were also two patients who had had twins, one had lost one of the
twins at birth and the other had one twin with special needs. Other delegates were
representatives from patient organisations attended and members of clinic staff.

Programme

The meeting started with a short introduction from Shirley Harrison followed by two
presentations from Jane Denton, Director of the Multiple Births Foundation, about
the risks of multiple births, and Roger Neuberg, a member of the Authority and
consultant obstetrician and gynaecologist at the Leicester Royal Infirmary,
discussing the regulatory options set out in the consultation. The full programme is
attached at Annex A and the presentations are attached at Annexe B.

Delegates were given the opportunity to ask questions about the presentations and
discuss the issues raised. They then separated into two breakout groups for the
discussion of two specific questions:

          What are the obstacles to change?
          What should the HFEA and clinics do?

The two discussion groups then fed back to the plenary discussion. Key points from
the discussions were put on slides and these are attached as part of the presentation
at Annex B. The whole group then had an opportunity to discuss the regulatory
options set out in the discussion document.

Plenary discussion

Shirley Harrison was questioned about the funding of infertility treatment on the NHS
and she informed them that she had had a meeting with the Minister to introduce
herself and that she recognises the need for a statement of intent from the
Government which defines a cycle of IVF as including frozen embryo transfers and
that without this statement it is unlikely that PCT’s will include frozen embryo
transfers.

One of the delegates asked about the policy review process and if the policy change
showed a fall in success rates if the policy would be readdressed. SH assured
delegates that there would be a review mechanism in place.


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There were issues raised by patients and clinic staff surrounding the presentation of
data and the format, highlighting the need for simpler, clearer information and patient
specific figures.

Patients said they felt victimised as IVF patients, when people having twins naturally
and, more importantly, those having IUI and ovarian stimulation, were left alone.

Delegates felt it might be useful for researchers to look in more detail at situations in
which two embryos had been transferred and resulted in a singleton pregnancy as
this may be transferable to single embryo transfer and deciding which patients it is
appropriate for.

The use of frozen embryo transfers (FET) was discussed and patients felt that there
is not enough information provided about FET’s and the specific outcome data is not
easily accessible or understandable. It was also suggested that clinics should give
patients more information about their freezing protocols before they begin treatment.

The patients in the group stated that the biggest risk to them is not getting pregnant
and therefore in comparison the risk of having twins and those twins being disabled
is very small.

Discussion groups

Information provision about multiple births
The majority of patients stated that they were given some information about the risks
of multiple births. However, many felt that the information was not sufficient to make
an informed decision about the number of embryos to be transferred. They also felt
that they receive so much information it can be confusing.

Patients were generally given information about the risks of multiple births at the
beginning of their treatment and it wasn’t brought up again. A lot of the information
they had they had found themselves. There were also issues raised about the fact
that the HFEA literature is only available electronically and therefore not accessible
to all patients.

What are the obstacles to change?
Funding of treatment: Patients felt that until the NHS funded cycles and provision
was equal across the country any SET policy would not be supported. One of the
key reasons stated for this was the extra costs of going through more cycles.

There are also differences in the definition of a cycle between PCT’s. In some cases
this does not include storage or frozen embryo transfers.

Success rates: There is a general concern that transferring one embryo would mean
that success rates dramatically reduce when they are already not very high. There is
also a common perception among patients that twins are a good treatment outcome.
Some patients would prefer to have twins as it means they do not have to have more
treatment to have a second child.




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Outcome data: The clinic data presented by the HFEA is often difficult for patients to
understand. There are also issues about working out the twin and multiple birth rates
and not enough accompanying information to make sense of the figures.

What should the HFEA and clinics do about it?
Patients felt that two sessions with doctors would be helpful so that they would have
time to digest the information after the first session and can have questions ready for
the second session.

Patients stated that there is usually a considerable amount of time between either
being referred by their GP or joining the clinics waiting list and getting an
appointment. It was suggested that the information about risks should be provided
when they were referred or joined the waiting list so that they have time to read and
understand the risks.

It was suggested that HFEA consent forms could include a check box that patients
must tick if they have received information about the risks of multiple births. Patients
felt that the risks of multiple births should also be discussed during implications
counselling sessions. However patients in the group had had mixed experiences of
counselling, some found it useful and others didn’t.

Some of the patients had found that during treatment their doctors were unavailable
and so highlighted the importance for the nurse practitioner to be able to give full
information about the risks of multiple births and answer any questions they may
have. The importance of offering proper training and support for members of staff
giving information about the risks of multiple births was also highlighted.

Consultation options

Option 1 was by far the most popular option and delegates felt that it should be
implemented regardless of the outcome of the consultation exercise. This was
because there is a recognised need for better patient information about the risks of
twins and multiples. It was also felt that this option ensured that patients had the
information to make the decision themselves with their doctor, and that the decision
could be made on a case by case basis.

Concerns were raised that the SET policy would mean that patients would have to
have a second cycle where, if they had had two embryos transferred the first cycle
would have been successful. There were also concerns that after the first cycle the
success rate would decrease and therefore their overall chance of getting pregnant
would fall.

Patients and clinic staff were very concerned that by setting a target (option 2) those
clinics who reached their target early on in the year would only transfer one embryo
to all patients to ensure that they were not penalised for exceeding the twin rate.
There were also concerns about clinics only selecting good prognosis patients to
ensure that in doing SET their success rates don’t fall.

There were also concerns that by setting the target the clinic/HFEA are saying it’s ok
to have 10% of live births being twins, but over that it starts to be a problem.



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Patients felt that option 3 gave clear guidelines, but were concerned that it was too
prescriptive. Delegates were concerned about the difficulties in identifying a good
prognosis patient as each patient is different and so by ‘putting patients into boxes’
their care and the likelihood of their treatment being successful may be
compromised. There were also concerns about embryo quality and criteria for
selecting a good quality embryo.




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                                                   HFEA (17/10/07) 401 – ANNEX D


Annex D: Evidence from the patient focus groups
In order to better understand patients’ concerns about multiple births and single
embryo transfer, we commissioned an external company, Opinion Leader, to run
three patient focus groups during May 2007. One group (London) consisted of
parents of IVF twins or singletons, another (Bristol) of prospective patients and a
third (Glasgow) of patients for whom treatment had so far been unsuccessful.
Although HFEA staff observed at each of the groups, the discussions at each of the
sessions were open and frank. Because the groups were hosted by a third party,
participants felt able to express themselves freely.

Opinion Leader will present their findings separately to the Authority. However, the
key messages for the HFEA from the focus groups were as follows:



Background
       The HFEA are conducting an extensive policy review into the problem of
        multiple births, particularly twin births, after IVF.
       The review explores whether single embryo transfer policies should be
        introduced into the UK fertility sector (they have been introduced
        elsewhere in Europe).
       Informed by an independent Expert Group set up by the HFEA.
       HFEA has issued a formal consultation document which anybody with an
        interest in the issues raised can use to feedback their views and they are
        also holding two public events for parents and doctors.
       In order to explore in more detail patients’ and parents’ attitudes towards
        the issues involved in this policy review, the HFEA decided to commission
        some qualitative research.

Objectives
        The specific research objectives for this study are:
         ◦    To explore/understand better the information, motivations,
              considerations, and value commitments that lie underneath patients’
              headline statements
         ◦    To understand how these different concerns and commitments are
              weighed up by patients
         ◦    What feeds into their concerns?
         ◦    What, if anything, would convince them of the need for single
              embryo transfer? Are there arguments or conditions that would help
              change patients’ attitudes to single embryo transfer?
         ◦    What exactly do patients know about twins and their problems?
         ◦    What do patients think the HFEA’s role is in this?
         ◦    How should regulation balance clinical and patient autonomy and
              concerns for the welfare of the children born?
        The outputs from this project will be used to shape policy that is patient
         focussed and sensitive to patient’s concerns




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Approach
        Three extended group discussions with patients with experience of IVF
         treatment, each lasting 2.5 hours:
         ◦     Those intending to start IVF treatment / just started IVF treatment
         ◦     Those currently having treatment who have been unsuccessful
         ◦     Those who have successful treatment
        Groups also represented a mix of NHS and privately funded participants
        There was a mix of socio economic grade and ethnicity across the groups
        Groups were conducted in London, Glasgow and Bristol
        Participants were recruited via two routes.
         ◦     Through invitations to participate posted on the TAMBA, MBF and
               Fertility Friends websites and via a Fertility Friends newsletter20
         ◦     Using specialist recruiters who made contact with clinics to invite
               patients
        In the groups 4 policy options were tested with participants:
         ◦     Option A: Increase awareness
         ◦     Option B: Set a maximum twin rate
         ◦     Option C: Develop Code of Practice guidance
         ◦     Option D: Combination of B and C

Overview
        Patients and prospective patients recognise and experience the
         emotional, physical and financial impacts of IVF treatment
        Although supportive of regulation in relation to unsafe/unscrupulous
         clinics, they are wary of the HFEA regulating on this issue, believing it
         reduces their already slim chance of success
        On the whole they are fearful of strict regulation surrounding single
         embryo transfer for a number of reasons:
         ◦      They do not believe that the risks associated with twins outweigh the
                risk of failure
         ◦      They do not believe that a simple formula can be created to issue
                guidance
         ◦      They believe they have the right and ability to make their own choice
                – if fully informed
        Despite resistance to regulation in general, patients welcome the
         Regulatory Option A : to increase awareness of the risks associated
         ◦      They believe this is the only way to ensure that all patients are
                treated as an individual and given a choice about their treatment
                options
         ◦      Whist it is recognised that this may not decrease the twin rate, it
                must be at least trialled to see if it has an impact
        All of the other options presented were rejected, as participants felt that
         these were unfair and removed the choice from their hands



20
   This will affect results regarding information sources as most participants were actively using the
internet for research and support purposes




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                                                       HFEA (17/10/07) 401 – ANNEX D


          They did believe that some form of guidance could be effective, if flexible
           enough to take into account individual circumstances

Different mindsets exist across the groups

 Considering IVF:            Unsuccessful IVF:             Successful IVF:
 Desperate                   Frustrated and angry          Relieved and
                                                           overjoyed
 Steep learning curve        ‘Experts’ - in their
                             opinion                       ‘Experts’ but…
 Rely on relevant
 networking websites         Rely on relevant              Wider influence,
 for information             networking websites /         including trusted
                             friends for information       consultants
 Fear of emotional,
 physical and financial      Limited resources;            More rational, less
 drain                       emotionally, physically       desperation
                             and financially
                                                           Those with twins
                                                           Sympathetic to HFEA
                            Looking for                    aware of the mindful
 Negative about HFEA, DHalternatives (e.g. going
                             and even clinicians in        in general, but
                                                           difficulties.
                                                           that regulation should
 general                    abroad, trying new
                            hospitals)                      focus on the outcome
 Should help not ‘hinder’ them have a child                 for the parents as well
                                                            as the children
 Main priority should be on improving success
 rates

  Distrust them, believe them to be biased
IVF treatment is a stressful experience
Treatment issues:



         Financial                            Emotional
         NHS cycles are not                   Couples undergoing IVF
         available to everyone:               treatment suffer emotional
         postcode lottery; previous           highs and lows. Low success
         children in the family etc.          rates add to the stress and
                                              gives rise to amateur theories
                                              for aiding success

                 Physical

                 For the woman, IVF treatment
                 is physically difficult:
                 Hormones; egg harvesting;
                 limited supply




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           So IVF patients wish to go through the experience as few times as
            possible

Information
         People who have experience of IVF treatment appear to have access to a
          lot of information, mainly that they have sought themselves:
          ◦      Fertility websites here and abroad (e.g. TAMBA/MBF/Fertility
                 Friends)21
          ◦      Social forums within these sites (many find these reassuring and a
                 place to find answers to questions and not all information good
                 quality or accurate)
         Few are actively using the HFEA website for information
         Few have developed good relationships with doctors and so were unable
          to ask specific questions
          ◦      Those undergoing NHS treatment rarely saw the consultant
          ◦      Nurse specialists appeared to be a better source of information for
                 patients

Quotes
            “I think the problem with the HFEA is their figures are actually quite out of
            date, I mean the latest ones are what at least 2 years out I think, no idea
            what’s happened in the interim.” Considering

            “this sort of review is based entirely on the risks to the mother and the
            children and it’s based on the NHS not wanting to spend money on
            intensive care beds” Considering

            “I met him, he took my hand, congratulated me on getting a successful
            cycle the time before, which I hadn’t and thought I was ten years older or
            younger – I can’t remember, I mean, he absolutely hadn’t got a clue.”
            Successful

            “Although sometimes the information in online communities is skewed. It
            is a bit odd sometimes, but I agree, you can get an awful lot of good
            information from that”. Successful

Summary of patients’ state of mind
       Those with experience of IVF, especially for those without a child:
        ◦    Are desperate, which means they can be irrational
        ◦    Feel frustrated due to poor success rates, multiple failed and
             unexplained cycles
        ◦    Do not feel treated as an individual – especially by the NHS




21
  Participants were recruited primarily through these sites and we would therefore expect them to be
using these sites for information




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           ◦     Feel unfairly treated (compared to other fertility treatment): Their
                 fertility treatment is regulated, whereas others and natural pregnancy
                 is not and they have to undergo a parenting questionnaire)
           ◦     Powerless: Not informed by professionals and not in control of their
                 treatment

Awareness and understanding of the issue
       Extremely high awareness of the issue of single embryo transfer and
        multiple births
       Information derived from a wide range of sources in the media and the
        HFEA website rather than from doctors
       Perceptions shaped and formed for many through forum/chat pages on
        fertility websites.
       Primarily understood to be restricting choice
       Adds to the feeling that those undergoing IVF treatment are subject to
        more scrutiny, regulation and control than those undergoing other fertility
        treatment, or any other childbearing/raising issue

           “I think generally speaking multiple births is a sort of downside of IVF in a
           way, but I would still rather be pregnant and be facing the issues that I will
           have to face with my twins, than not having the opportunity to have any
           children.” Successful

           “I do think about it. But a) I know we’d cope with twins, b) the risks of
           problems with a twin birth are still small even though they are elevated as
           compared to singleton birth, they’re still tiny and as the HFEA document
           points out the vast majority of twins are ok in the end” Considering

           “To try and put people off; you know, if you come out with all this
           bureaucratic drivel as of immature age and I mean people, well women,
           have been having twins for years, natural and they’ve all had normal
           pregnancies”. Unsuccessful

           “I think there should be consultation. I would be very unhappy because in
           no other areas in my medical life would I expect the doctor to make all the
           decisions. I rely on their advice and their support, but I would want to be
           involved with it“ Successful

           “Yes I do think the question of choice needs to be there as well, you have
           the choice, even as it is you have the choice to have one replaced”
           Considering




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Spontaneously mentioned risks and benefits of twins
 Benefits                                      Risks

 Instant family (especially for those          Aware of risks to the baby – still birth,
 childless)                                    low birth rate, respiratory difficulties

 Suffer less financial, physical and           Aware of risks to the mother -
 emotional burden long term through            depression, pre-eclampsia
 reduced cycles.
                                                Those with twins also consider the
 “Getting it all out of the way”                financial and physical strain placed on
 Considering IVF IVF patients know the risks, theyfamily
           Even if                             the (especially those childless) just
            hope that they would not be in the unfortunate minority that suffer
 Believed to be good for the twins
            difficulties
 Playtogether well, havedo special bond, the risks are that significant
            Indeed, some a not believe that
     
 are specialThey claim that risks do not outweigh the desire to have a child. They
            would deal with any consequences that arise as a result

Some key risks not known / appreciated
       Although IVF patients are aware of risks few have had information
        presented in a clear and unbiased format
       They do not believe the HFEA information is full and unbiased however it
        did alert them to a few risks not previously considered

 Risks

 A greater chance of needing to have a C Section

 The greater stress on the family resources

 The greater chance that mother and babies might not be able to be cared for
 in the same place

 For successful patients, the key point was that risks were avoidable. For other
         However, some questions remain unanswered
 groups, this was dismissed
          ◦    Are risks specific to IVF twins or do ‘natural’ twins have the same
               complications?
          ◦    Are twin births biased towards older mothers? If so does this skew
               the results because of the risk factors associated with pregnancy in
               older women?

Experience of SET
        The majority were aware of the proposals for Single Embryo Transfer but
         few had discussed it at length with doctors
        Only one in the sample had opted for SET wishing to avoid the risk of
         having too large a family (and another was planning to opt for 2 rather
         than 3)
         ◦    NB she actually ended up with twins and is thankful she does not
              have four.



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          A minority had discussed it with doctors and opted for two embryos to be
           transferred, given:
           ◦     The perceived low chance of conceiving twins
           ◦     The perceived poor chance of success anyway
          Others had not been consulted but opted for two embryos on the basis
           that they perceived this offered more chance of success.

Understanding of SET
        Two key concerns surround SET
         ◦   How can it be as successful as transferring two embryos?
         ◦   How can they know which embryo to transfer?

           “My embryologist couldn’t tell me which one gave me my daughter. To
           him, both embryos were perfect. They could have chosen the other one
           with SET” Successful

          In summary, they believe that SET decreases an already slim chance of
           success
          They are therefore very resistant to it as a rule for all women who are
           more likely to conceive

Reactions to Internationals SET
        IVF patients reject comparisons to other countries
         ◦     Perceive other countries, particularly Scandinavian countries, have
               better success rates and more advanced procedures
         ◦     Believe rates to be cheaper and more cycles available on the State
         ◦     Not sure if it is like for like
         ◦     Believe that a biased viewpoint is always presented
        Comparisons anger IVF patients

           “Why aren’t they over there working out how to get better success rates”
           Unsuccessful

          Those considering IVF also believe that claims that success rates stayed
           the same in those countries who adopted SET are not good enough as
           success rates should be increasing in line with technological
           improvements

Key lessons about SET
        SET is chosen by some IVF patients through choice
         ◦     Those that had seriously considered it had been given a lot of
               information by their doctors
        Some successful patients believe they may opt for it if they went for
         further IVF treatment
         ◦     Based on the rationale that they don’t want two further babies, rather
               than health implications
        Those yet to be successful reject SET given the perception it decreases
         their already slim chance of success



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          The introduction of frozen cycles included in the same payment is
           welcomed, but many fears and concerns surround failed frozen cycles
          Further NHS cycles available for all couples is also welcomed, but again,
           there are emotional, practical, physical and time factors involved in IVF
           treatment which patients are keen to avoid.

The role of the regulator – The need to reduce multiple births
         The participants were split in their agreement with the HFEA that there
          needs to be a reduction in twins

           “Well I can see why they should reduce the twins, it’s not easy”
           Successful

           “I don’t actually think, I am quite surprised by those; I thought there would
           be more, more complications” Unsuccessful

          Some are cynical, believing that the proposed restrictions only serve to
           save costs for the NHS
          Successful patients with twins were inclined to agree that there was a
           need to reduce multiple births but not at the expense of patients’ success
           rates

The role of the regulator – their involvement
         IVF patients are against a heavy handed approach from the HFEA
         Some also reject the HFEA as an authority believing them not to have
          specialist knowledge
         They want them to:
          ◦     Focus on inspecting clinics and work on sharing best practise to
                increase success rates overall
          ◦     Speak up for people going through IVF (not be a barrier to them) to
                deal with current issues: Low numbers of donor eggs/sperm and
                postcode lottery for people receiving free cycles

           “A good regulator … they listen to what people are saying, they take on
           board these things, they make recommendations and sometime these
           recommendations have at times worked and sometimes fallen through.
           [The HFEA are] making all these ideas saying all this but I don’t see them
           giving us as the clients here anything back”

          On this issue of multiple births and single embryo transfer, they resist any
           regulation that takes away individual choice / reflection
          Many believe that changing the way doctors report their success rates
           should change, from successful births to successful deliveries. This would
           provide no further incentives to clinics to opt for multiple embryo transfer if
           it is not appropriate.

           “They’re making it more difficult for women to be pregnant and more
           difficult for people who’ve already been through an incredibly tough time”
           Unsuccessful



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           “I mean the HFEA…they’re funded by some government department,
           government wants to save money - likelihood is no IVF will be on the NHS
           soon… Twins cost the NHS money” Considering

           “The only way would be to get the success rates up. If you got the
           success rate up then none of these problems … well, a lot of them would
           be eradicated“ Successful

HFEA’s Options
 Accept                                                                Rejected
 ed
                                                   Option B:       Option D:
  Option A:                                        Maximum         Combination
  Increase                                         twin rate
  awareness
                                                           Option C:
                                                           Code of
                                                           Practice


* If guidance is flexible rather than fixed then they would be more supportive

Option A – Increase awareness
        Preferred option
         ◦     Only option that is acceptable for some
         ◦     Necessary first step for most
        Information should be balanced and unbiased, from an independent
         source
        HFEA should put pressure on clinics to ensure they are doing this. Clinics
         should also be encouraged to offer counselling to help couples make
         decisions
        A minority recognised that this may not have any impact on reducing the
         twin rate, understanding that people would still rather have two embryos
         transferred to maximise success

           “Increased awareness but I would say when they say encourage
           increased use they mean encourage information but then leave the
           person to decide for themselves“ Successful


Option B – Set a maximum twin rate
        Rejected by the majority
        Main concerns surround the selection process
         ◦     Discriminate against women who are more likely to require two
               embryos transferred
         ◦     Clinics may not use the best treatment option for the individual,
               focussing instead on their targets




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           “I do think some target setting might be a good idea but it’s how you set
           the targets.” Successful

           “I wonder whether in this option whether again private sector clinics might
           be disincentivised to choose women with a low outcome; with a low
           prognosis if they have to. Because they'd want to keep their pregnancy
           rates high” Unsuccessful


Option C – Develop a code of practice guidance
        As a guideline; some support. As a rule; rejected
        Are in favour of a consistent approach across clinics
        Main concerns surround the lack of tailored treatment
         ◦     Don’t believe the guidance will involve the flexibility to cater for
               individual situations
        Some IVF patients think they would fall into the category and would reject
         an imposed guidance as this would restrict their chances of success
         unfairly
        If guidance was developed, embryo quality, preferably to blastocyst stage
         should be the main criteria

           “I don’t see how they can pick out the right people” Considering

           “See I really hate that because that someone making my decision not my
           clinician who know my case. And it’s generalising again from the
           population that it might not necessarily reflect in my circumstances”
           Successful

Option D – Combination
        Rejected
        Takes the control away from the patient entirely
        Focussed purely on twin rates and not the needs of the patient

           “So where is my choice in this, it’s all up to the HFEA and the
           clinician…treated just like another number” Successful

           “So whilst I don’t like the maximum twin rate for other reasons, that I
           prefer to having a strict set of criteria that, you know, you have Grade 1
           embryos and you’re under 35, you’re only going to have one put back.
           Because I don’t think that will necessarily meet individual circumstances
           and maintain the pregnancy rate.” Successful

Overall Reactions
         IVF patients on the whole, reject all options with the exception of A
         Crucially, they point out that couples would be more tempted to travel
          abroad for treatment
         This would be out of the HFEA’s control and couples may even opt to
          transfer three or four embryos
         If these resulted in successful pregnancies the risks to babies, mothers,
          families and the health system associated with multiple births would be


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           greater than previously

           “We’ve just come back from Istanbul, we had three put back. This won’t
           work because people will go abroad and have four or five put back and
           then the burden will be even more on the NHS” Unsuccessful

Key conclusions to feed into the consultation
        Patients considering or undergoing IVF treatment are clearly desperate to
         have a child. They are already frustrated that success rates are low in the
         UK.
        They do not believe that success rates will stay the same with SET.
        They reject any policy they see as potentially decreasing further their
         chance of success, albeit for the better safety of the prospective children.
         They believe that their needs should equally be taken into account.
        Many do not believe that the potential risks to twins and mothers are
         enough to warrant this policy.
        The main fears surrounding single embryo transfer are; the potential lack
         of choice if rigid rules are brought in specifying who should receive two
         embryos and who one; the current lack of knowledge amongst
         embryologists and doctors about why some embryos successfully take
         and why others don’t
        They become more in favour of SET if more cycles are offered on the
         NHS and or frozen cycles are included, however these still have
         limitations given the emotional, practical and physical effects of going
         through IVF treatment.
        They are most in favour of Option A which gives them more information to
         make an informed decision.
        Other options are rejected unless option C is a guide rather than a rule, to
         include some flexibility for specific cases.




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Annex E: Current HFEA guidance
Guidance 5.3.2 Information provision: multiple pregnancy
Where the treatment involves the use of superovulatory drugs or the transfer of
multiple embryos in any one cycle (whether fresh or previously cryopreserved) the
centre should give people seeking treatment information about the risks to the
woman, fetus and any resulting child associated with multiple pregnancy, including:

          the level of increased risk of miscarriage and complications such as raised
           blood pressure; and
          the higher incidence of premature birth that is associated with multiple
           pregnancies, including reference to the problems of low birth weight,
           increased still birth and perinatal mortality; and
          the increased incidence of disability and other health problems associated
           with multiple pregnancy, as well as the potential need for extended stays
           in hospital both before and after birth; and
          the possible practical, financial and emotional impact of a multiple birth on
           the family unit and the individual children.

6.2.4 Consent: number of eggs or embryos to be transferred [Consent section]
Where a woman is to undergo an egg or embryo transfer the centre should obtain
her consent to the proposed number of eggs or embryos to be transferred, and place
a record of her consent in the patient records.

8.2.2 Consent: number of eggs or embryos to transfer [Use of gametes and
embryos section]
Where a woman is to undergo an egg or embryo transfer the centre should discuss
with her the appropriate number of eggs or embryos to be transferred, and the
reasons for this (including the risk of multiple births), obtain her consent to the
proposed number of eggs or embryos to be transferred, and place a record of her
consent in the patient records.

8.5.1 Risks: number of eggs or embryos to transfer
Where a woman is to receive treatment using her own eggs, or embryos created
using her own eggs, whether fresh or previously cryopreserved:

          where the woman is aged under 40 at the time of transfer the centre
           should not transfer more than two eggs or two embryos in any treatment
           cycle, regardless of the procedure used;
          where the woman is aged 40 or over at the time of transfer the centre
           should not transfer more than three eggs or three embryos in any
           treatment cycle, regardless of the procedure used.

8.5.2 Risks: number of donated eggs or embryos to transfer
Where a woman is to receive treatment using donated eggs or embryos, or using
embryos created with donated eggs, the centre should not transfer more than two
eggs or two embryos in any treatment cycle, regardless of the woman’s age at the
time of transfer and regardless of the procedure used.




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Annex F: Multiple Births in the United Kingdom: a consensus
statement
This consensus paper follows a meeting which took place on 23 January 2007 in
London. This was convened by the Human Fertilisation and Embryology Authority
(HFEA).

Participants

Professional organisations
         Association of Clinical Embryologists
         British Fertility Society
         British Infertility Counselling Association
         Multiple Births Foundation
         Royal College of Midwives
         Royal College of Nursing
         Royal College of Obstetricians & Gynaecologists
         Royal College of Paediatrics and Child Health

Patient organisations
          ACeBabes
          BLISS: The Premature Baby Charity
          Daisy Network
          Donor Conception Network
          Endometriosis UK
          Fertility Friends
          Infertility Network UK
          Miscarriage Association
          National Gamete Donation Trust
          Surrogacy UK
          Twins and Multiple Births Association

Others
          National Perinatal Epidemiology Unit


Multiple births in the UK

The hazards of multiple pregnancy present the biggest risk to the health and welfare
of children born as a result of IVF. A comprehensive analysis of the consequences of
multiple pregnancies has recently been published. The HFEA report produced by the
Expert group on multiple births after IVF has provided irrefutable evidence that the
extraordinary rise in the prevalence of twin births in the UK is, in the main, due to
fertility treatment, particularly IVF.

Over 40,000 IVF cycles now take place in the UK each year, with average pregnancy
rates following treatment now over 25% per cycle initiated. One in four pregnancies
derived from IVF results in a twin birth – a ten-fold increase in risk over natural
conception. Given the major immediate and long term consequences for women and
particularly the children associated with twin birth, this level of demand on maternity,


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neonatal paediatric and child health services presents major problems for the state
funded health sector.

A multiple pregnancy should not be regarded as the ideal outcome of IVF treatment.
While two healthy babies may be born, twin pregnancies can result in adverse
outcomes for both mother and child. With IVF associated conceptions now
accounting for in excess of 1% of UK births, the aim must be to ensure that these
children are afforded the maximum chance of a healthy start in life.

The direct link between the number of embryos transferred to the uterus during IVF
treatment and the chance of twin pregnancy is beyond dispute. It is the view of the
organisations contributing to this document that, with much of Europe now offering
elective single embryo transfer as the norm, continued high multiple embryo transfer
and twin pregnancy rates are impossible to justify.

Measures to reduce the burden of twin pregnancies will need to take account of the
many and complex influences on clinical and laboratory practice in the UK.

This consensus statement brings together the views of providers of treatment
(clinicians, scientists and counsellors), midwives, obstetricians, paediatricians, and
patient organisations including those with experience of multiple births. The
participants recommend that the Minister of Health give consideration to the issues
raised in this document.

Key point

The only way to reduce multiple birth rates after IVF is to transfer only one embryo to
those women at most risk of having twins. Elective SET and cryopreservation of any
additional suitable embryos should be standard practice in good prognosis IVF
patients.

Consensus views

Information prior to treatment
1. Twin pregnancies carry much higher obstetric risks for women.

2. Multiple birth is the single biggest risk to the health and welfare of children born
after IVF.

3. Reducing death and disability in children conceived following infertility treatment is
of concern to commissioners, providers and recipients of care.

4. It is the duty of those providing infertility treatments including IVF, to take account
of potential adverse obstetric outcome, particularly those associated with multiple
pregnancies.

5. The goal of all fertility treatments should be the delivery of a single, healthy child,
born at full term. This is the safest outcome for both the mother and child.

6. At the outset, in providing fertility care, clinic staff should make clear to patients
considering treatment that the interests of the prospective child are of major
importance.


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7. Responsible public education initiatives are required to appraise patients, and the
wider public, about potential adverse outcomes of twin pregnancies.

8. The media should ensure that reporting of issues surrounding multiple births is
accurate, informed and avoids sensationalism.

9. Robust national guidelines, complementing existing international datasets, on
patient and embryo profiles generating high risk of multiple pregnancies after double
embryo transfer are required.

10. Prospective patients, with a good prognosis, should be advised that a single
embryo transfer policy involving fresh followed by frozen single embryo transfers,
can virtually abolish the risk of multiple pregnancy while maintaining a live birth rate
the same as that achieved by transferring two fresh embryos.

Provision of care
11. High rates of multiple pregnancies derived from IVF treatment in individual
centres are no longer acceptable. Providers of IVF should endeavour to identify
those women at significant risk of multiple pregnancies through treatment. Single
embryo transfer (SET) in good prognosis patients should be offered as a matter of
routine.

12. Centres should refer to good practice guidelines as these evolve, as well as
regulatory requirements, in developing protocols for SET taking account of
prognostic indicators, such as female age and available embryo quality. Egg
donation cycles may be at particular risk of multiple implantations where more than
one embryo is replaced.

13. Fertility centres must have audit processes in place monitoring embryo transfer
practice and consequent implantation rates.

14. The role of the regulator in developing change in clinical practice in the UK is
extremely important. Historical evidence would suggest that a degree of proscription
is likely to be required to facilitate change in practice and attitudes. The HFEA is
launching a consultation which seeks the views on various options, amongst them:

          a. The regulator could proscribe a requirement of IVF treatment centres to
           reduce multiple pregnancy rates to <10% of the total pregnancies per
           initiated cycle.
          b. The regulator could adopt an approach in only permitting SET in the
           first cycle of treatment in patients under the age of 35 years. This would
           be similar to state funded treatment in Belgium.
          c. Where blastocyst transfer is contemplated the regulator could insist that
           in all cases only a single blastocyst is transferred.

Further responses by all the relevant parties on this issue to the HFEA consultation
will be of considerable interest.

15. Prognostic indicators based on embryo quality will, as knowledge increases, be
refined. Efforts such as the Department of Health funded TowardSET Project
(Manchester) will be expected to provide major assistance in this area over the next


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two years. Regulatory processes should ensure that any national SET policies based
on embryo quality and other variables may be changed without major bureaucratic
complexity.

16. Those providing care in the private and NHS sector should be bound by the
same proscription on embryo transfer practice and multiple pregnancy rates.

Commissioning care and national funding
17. Commissioners should take account of multiple pregnancy rates of centres with
whom they contract, and insist on maximum acceptable twin pregnancy rates per
cycle initiated e.g. 10%.

18. The definition of a single full treatment cycle is the replacement of a fresh
embryo and subsequent replacement of all the frozen embryos derived from that
cycle. Adherence in this way to the NICE Guideline would encourage and not
disadvantage patients agreeing to SET.

19. Inadequate implementation of the NICE Guideline on Fertility (2004) has had a
fundamental part to play in the failure of UK IVF centres to adopt single embryo
transfer policies. Patients have, as a consequence, frequently found it difficult to
accept SET in their own treatment, conscious that electing to have a single embryo
transferred, in what could be their only state funded IVF cycle, might reduce their
chance of a child.

20. Commissioners must, as a minimum in the first instance, acknowledge the need
to fund a single cycle of IVF (fresh plus the thawed embryo transfers) in line with the
Secretary of State for Health’s instruction at the time of the launch of the NICE
Guideline.

21. The Department of Health must encourage commissioners to consider full
implementation of the NICE Guideline. If three full cycles of IVF care were to be
provided by the State, then the pressure on patients accessing self funded care to
decline elective SET would reduce.

22. Variation in provision will inevitably continue whilst there remains local
determination on commissioning priorities and little follow-up monitoring of
implementation of the NICE Guideline by the Department of Health.

23. The Department of Health should encourage commissioners to adopt national
uniform criteria for contracting with IVF providers, particularly with respect to the
definition of a treatment cycle i.e. fresh plus thawed embryo transfers.

24. NHS contracts with fertility clinics should include reference to professional good
practice guidelines, where available, aimed at reducing multiple births.

25. Clinics should consider the development of pricing policies which make elective
SET attractive to both commissioners and patients.

26. Guidance on commissioning should be uniform across the whole of the UK.




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Reporting outcomes
27. Paediatric follow-up studies on fertility treatment associated pregnancies are
hampered by constraints on disclosure as dictated in current legislation governing
the work of the UK regulator. This legislation should be revised to allow greater co-
operation between fertility specialists, obstetricians and paediatricians. In addition
linkage of the Authority database to other national databases e.g. the National
Childhood Cancer Registry would facilitate important epidemiological research.

28. The regulator should report clinic data in such a way as to encourage good
practice in relation to embryo transfer policies. Reporting cumulative pregnancy rates
per initiated cycle i.e. including fresh and frozen/thaw transfers would be desirable.

Support for neonatal and child health services
29. Neonatal care facilities in the UK should be organised and equipped to provide
the best care possible for all children, including those derived from multiple birth.

30. Neonatal health care services are under considerable strain in the UK,
exacerbated by high numbers of multiple births. Significant adjustment of the
pressures in neonatal care can be expected through the adoption of a national SET
policy within the UK enabling more resources to be available for the provision of
increasingly complex and expensive care, essential for some babies, whether
conceived naturally or after fertility treatment.

Conclusion

The evidence base linking the practice of multiple embryo transfer and the
consequent establishment of pregnancies at significantly greater risk of serious
complications is irrefutable. The health benefits to children, the reduction in distress
for families and the enormous cost savings for society, through reduction in need for
immediate and long term health care for affected children, make an overwhelming
case for change in this area of clinical practice. Modification of embryo transfer
practice through careful patient and embryo selection can significantly reduce the
risk of such hazards.




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