Overview Definitions Family Planning Natural Family Planning by mikeholy

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									                                                                             Overview

                                                                                Definitions
              Scientific basis of Fertility Awareness-                          A brief history
              based Methods (FAM)                                               Basic concept of FA
                                                                                Some remarks on contraceptive efficacy
                                                                                Conclusions
              Yves Jacquemyn
              UZA
              UA




                                                                             Family Planning

                                                                                WHO: Family Planning implies
                                                                                 – the ability of individuals and couples to anticipate and attain
              Definitions                                                          their desired number of children
                                                                                 – and the spacing and timing of their births.
                                                                                It is achieved through
                                                                                 – use of contraceptive methods
                                                                                 – and the treatment of involuntary infertility



                                                                             WHO 1997




                                                                             FAM is used
           Natural Family Planning
                                                                             (Population reference bureau 2002)
             Natural Family Planning refers to techniques for
             planning or preventing pregnancies by observation of                                   7     3

             the naturally occurring signs and symptoms of the                                                                        FAM
                                                                                                                   17
             fertile and infertile phases of the menstrual cycle                                                                      Sterilization
                                                                                                                                      pill
                                                                                         15
                                                                                                                                      iud
                                                                                                                                      condom
                                                                                                                                      withdrawal
                                                                                                                                      other
                                                                                                9             14


                                                                    In % for “more developed countries”
           WHO 2000




Jacquemyn: Scientific basis


                                                                                                                                                      1
                                                                                                                   ovulatory phase ovulation           luteal phase

                                                                                                       ovary


                                                                                       The cycle
                                                                                                                                                             progesterone
                                                                                                       hormones

           Fertility Awareness-based Methods (FAM) involve                                                        oestrogen


              – identification of the fertile days of the menstrual cycle,
                  • whether by observing fertility signs such as cervical secretions
                                                                                                       symptoms
                  • and basal body temperature,
                  • or by monitoring cycle days.
                                                                                              mucus
             FAM can be used in combination with
                                                                                                                   dry     moist         wet        moist          dry


              – abstinence or                                                                 cervix
                                                                                                                     hard     softer     soft               hard
              – barrier methods
                                                                                                                                                       high
                                     during the fertile time.                                 temperature            low


                                                                                              menstruation
           WHO 2004
                                                                                                                                       cyclusduur




                                                                                          Bible: lapse of 7days from the end of menstruation (Leviticus XV, 19-28)
                                                                                           – 15:19 And if a woman have an issue, [and] her issue in her flesh be blood, she
                                                                                             shall be put apart seven days: and whosoever toucheth her shall be unclean
              A brief history                                                                until the even
                                                                                           – 15:28 But if she be cleansed of her issue, then she shall number to herself
                                                                                             seven days, and after that she shall be clean.
                                                                                          3th century; Rabbi Jochanan (Bawli Nidda 31b): a woman gets pregnant
                                                                                          only in the time close to the ritual bath
                                                                                          Time limited viability of sperm is known in jewish tradition, but discussion on
                                                                                          period
                                                                                           – 48 to 72 hours
                                                                                           – Eg Maimonides (12th Century)
                                                                                             (Hilg. Sjear Hattoem-a 5:11, 12): 12 hours




           To achieve a pregnancy                                                        To avoid a pregnancy
          Discovery of basal body temperature shift
           – 1868 W Squire                                                                Calendar method
                                                                                           – 1930 Johannes NJ Smulders
           – 1876 Mary Putnam Jacobi
                                                                                          Temperature method
           – 1905 Theodoor Hendrik Van de Velde
                                                                                           – 1954 Gerhard Döring
          Ovulation time                                                                  Mucus method
           – 1924 Kyusaku Ogino                                                            – 1964 John and Evelyn Billings
           – 1929 Hermann Knaus                                                           Symptothermal method
           – Proved by                                                                     – 1965 Joseph Rötzer
              • 1931 Lewis (during surgery)                                                – 1982 Anna Flynn
              • 1930 Allen, Pratt Newel and Bland                                          – 1987 Arbeitsgruppe NFP




Jacquemyn: Scientific basis


                                                                                                                                                                              2
                                                                    Scientific basis

                                                                     Double Concept

             Basic concept of FA                                     Fertile period in a menstrual cycle
                                                                     Determine this fertile window in an easy way




           Scientific basis                                         Fertile period : sperm
            Double Concept                                           Viability of sperm?
                                                                     1903 Birsch-Hirshfeld: autopsy after murder durante
            Fertile period in a menstrual cycle                      coitum: vital sperm in tube 14-16 hours later
             – Timing of ovulation
             – Limited ovum viability                                1923 Stecher (Zurich) in female genitals only vital
             – Limited sperm viability                               sperm for 24 hours after coitus
            Determine this fertile window in an easy way             Mobile sperm has casuistically been found up to 8.5
                                                                     days after coitus




           Fertile period : sperm                                   Fertile period: ovum

            Viable sperm in fallopian tubes up to 80 hours that      1931 Lewis (during surgery) fresh undivided ovum in
            perform normally with zona-free hamster oocytes          tube , 14 days before next menstruation
            (Gould , Biol Reprod, 1984)                              1930 Allen, Pratt Newel and Bland: found 5 human
            In animals: fertilizable lifespan = ½ motile lifespan    ova during surgery 1 day 14, 1 day 16 and 3 day 15
            Most common estimate: 18 to 12 hours                     after last menstrual period




Jacquemyn: Scientific basis


                                                                                                                           3
                             Fertile period: ovum                                                                                                        Ovulation and fertilization

                              Viability of the ovum was until recently a black hole in
                              our knowledge: no direct observations possible until
                              IVF
                                   – Immature human eggs recovered for IVF can be fertilized
                                     even after 36 hours of incubation
                              But IVF not representative of physiological state                                                                      Up to 4 days + 1 day
                              12 to 24 h is generally accepted
                                                                                                                                                          maximum 5 days common fertility
                                                                                                                                                           of man and woman in a cycle
                                                                                                                                                                   But when is ovulation?




                                                                                                                                                                                    ovulatory phase ovulation             luteal phase

                                                                                                                                                                        ovary

                             Fertile period: timing of ovulation                                                                                     The cycle
                                                                                                                                                                                                                                progesterone
                                                                                                                                                                        hormones

                              The time from ovulation to the next menstruation is                                                                                                  oestrogen
                                                                                                                                                                                   VARIABLE                        CONSTANT
                              constant 12 to 16 days
                                                                                                                                                                                   5d
                              The time from the previous menstruation to ovulation                                                                                      symptoms

                              is variable!!!
                                                                                                                                                               mucus
                              There is no ovulation in the first 5 days of a cycle,                                                                                                 dry       moist         wet        moist          dry

                              endometrium is building up                                                                                                       cervix

                              MOST WOMEN DO NOT HAVE REGULAR 28 DAYS                                                                                                                    hard     softer     soft               hard

                              CYCLES                                                                                                                           temperature              low
                                                                                                                                                                                                                          high



                                                                                                                                                               menstruation

                                                                                                                                                                                                          cyclusduur




                             The physiologic reality                                                                                                     Possible influences on the cycle
                                                                                                     n = 5 037 cycles                                                                Disease travel
                         Variability of cycle length                                                 n = 423 women
                              70%: 25 – 31 days                                    Variability within same woman
                                                                                                                                                               joy
                                                                                                                                                                                                                       diet
          14                                                          25


          12
                                                                      20                                                                                stress                                                             Night duty
                                                                      15


                                                                                                                                                       cerebrum
          10                                                          10

                                                                      5
          8
                                                                      0
                                                                           tot 3     4-5    6-7   8-9   10-11   12-13   14-15   16-17   18 en
                                                                                                                                                R1
                                                                                                                                                                                                                               Mandate for
          6                                                                                                                             meer
                                                                                                                                                      cerebellum                                                               FSH and LH
          4
                                                                                                                                                                                                                               production
          2
                                                                                                                                                      hypothalamus
          0
               tot 21   23    25     27   29   31   33    35     37        39       41 en
                                                                                    meer                                                                  hypophysis


     www.uni-duesseldorf.de/NFP Ärztliche Praxis Gynäkologie 2005:5




Jacquemyn: Scientific basis


                                                                                                                                                                                                                                               4
           implication                                     Scientific basis

            There is an important variability regarding     Double Concept

            ovulation, even within the same woman:          Fertile period in a menstrual cycle
                 For high efficacy in preventing a           – Timing of ovulation
                                                             – Limited ovum viability
             pregnancy, a calendar method is unsafe.         – Limited sperm viability
                                                            Determine this fertile window in an easy way




           Scientific basis                                Symptoms: symptothermal methods

            Double Concept
                                                            Basal body temperature
            Fertile period in a menstrual cycle             Cervical mucus
             – Timing of ovulation
             – Limited ovum viability
                                                            Cervical position
             – Limited sperm viability                      Cervical consistency
            Determine this fertile window in an easy way
             – Calendar?????
             – Symptoms
             – Biological measurements




           Biological measurements                         Fertile ?

            Microscopy saliva: ferning
            Urinary LH




Jacquemyn: Scientific basis


                                                                                                           5
           Yes, at least fertile !                                    Fertilization condition
                                                                         1948 Erik Odeblad (Sweden) predictable cyclic mucus
                                                                         changes (while studying mycoplasma)




                                                                         1962 Edward F Keefe: physical changes of the cervix
                                                                         throughout the menstrual cycle




           Oestrogen

            Stimulates mucus production                             Wenn in the 1st      It most is white, The more
            Builds up the endometrium                               cycle phase you      thick and sticky oestrogens, the
                                                                    see first mucus                        clearer it becomes
            Opens and softens the cervix and causes the cervix to
            rise in the vagina



                                                                    Around ovulation it                     After ovulation it
                                                                    looks often like    is very stretchy.   soon becomes
                                                                    raw egg white and                       thick and
                                                                                                            disappears.




                                                                    Under influence              Under influence of
                                                                     of oestrogens                 progesteron




Jacquemyn: Scientific basis


                                                                                                                                 6
              Progesteron                                                           How it all fits together

                   Mucus plug
                   Develops endometrium
                   Suppresses a new ovulation
                   Elevates basal body temperature




                                  VIABILITY OVUM
                      VIABILITY SPERM

                                  OVULATION

                       FERTILE                WINDOW                                           FERTILE                WINDOW




                                                                                                                   PROGESTERON RISE
                                                                                                                           TEMPERATURE RISE

                                                                                                                      CHANGE IN CERVICAL MUCUS_
                                                                                                                      POSITION_CONSISTENCY




                                        CONSTANT 12-16 DAYS
                                                                                    The fertility cycle
    MENSES                                                      MENSES

    VARIABLE BUT
                                                                                                                    18 hours
    5 DAYS SAFE
                       FERTILE                WINDOW                                                       ovulation



                                                                          Increasing
                                                                          probability
                                                                          of pregnancy



                                        PROGESTERON RISE                                  relatively     fertile        absolutely unfertile
                                                                                          unfertile
                                                   TEMPERATURE RISE

                                              CHANGE IN CERVICAL MUCUS_
                                              POSITION_CONSISTENCY
                                                                           Menstruation                  Duration of a
                                                                                                         menstrual cycle




Jacquemyn: Scientific basis


                                                                                                                                                  7
                                                                                        What is the real failure rate of
                                                                                        contraception?
                                                                                          Users = real life population study
             Some remarks on contraceptive                                                In a population comparable to your own: US ≠ Europe
             efficacy                                                                     An example (Moreau et al. Hum Reprod 2007)
                                                                                          French population based study
                                                                                          1689 women, 18-44 years




           What is the real failure rate of                                             What is the real failure rate of
           contraception?                                                               contraception?
            First year                                                                    First year
                                                                                                                          Major difference with US
             – Overall 2.9% failure                                                        – Overall 2.9% failure
                                                                                                                          (Kost et al, Contraception 2008)
             – Failure rate per method                                                     – Failure rate per method
                                                                                                                          Pill 7%
                •   IUD 1.1%                                                                   •   IUD 1.1%
                •   Pill 2.4%                                                                  •   Pill 2.4%              Condom 17%
                •   Condom 3.6%                                                                •   Condom 3.6%            FAM 25%
                •   FAM: 7.7%                                                                  •   FAM: 7.7%              Withdrawal 18%
                •   Withdrawl 10.1%                                                            •   Withdrawl 10.1%
                •   Spermicides 21.7%                                                          •   Spermicides 21.7%      And no improvement between
                                                                                                                          1995 and 2002

                                                                                 This is no Pearl index or lifetimetable!




           What is the real failure rate of                                             What is the real failure rate of
           contraception?                                                               contraception?
            First year                                                                    Real life always higher compared to “studies”
                                              Major difference with US
             – Overall 2.9% failure                                                        – Bias
                                              (Kost et al, Contraception 2008)
             – Failure rate per method                                                     – People will be performing better as long as they are
                                              Pill 7%
                •   IUD 1.1%                                                                 “monitored”
                •   Pill 2.4%                 Condom 17%
                                                                                           – Motivation in a study is high
                •   Condom 3.6%               FAM 25%!
                •   FAM: 7.7%                 Withdrawal 18%
                •   Withdrawl 10.1%
                •   Spermicides 21.7%         And no improvement between
                                              1995 en 2002

                    Are Americans more clumsy or more fertile???




Jacquemyn: Scientific basis


                                                                                                                                                             8
           FAM: Cochrane review                                          FAM: cochrane review

            Grimes, Gallo, Halpern, Nanda, Schulz and Lopez               All RCT on any FAM
            2004                                                          Any language
                                                                          Compared with placebo, another method, alternative
                                                                          FAM




           FAM: cochrane review                                          FAM: Cochrane review
            Only 8 studies                                                Conclusion
            3 methodologically acceptable for review                      – Such poor quality that it is impossible to determine comparative efficacy
            Including < 2000 women in all 3 studies taken together
            None of the studies even mentions the randomization method    – Just as every other method of contraception FAM should be properly
                                                                            evaluated, in RCT?? , before adoption and dissemination
            Non compliant couples were encouraged to discontinue….
                                                                          – But: is an RCT acceptable for contraception in the 21st century?
            > 50 % drop out (if > 20 %: trial validity extremely low)
                                                                          – Is an RCT the best method, are descriptive studies enough?




           Problems when studying FAM                                    Problems when studying FAM

            Mixture of methods                                            Mixture of methods
                                                                          –   Creighton model fertility care system
                                                                          –   Billings ovulation method
                                                                          –   Ogino Knaus
                                                                          –   Smulders Ogino
                                                                          –   Perimon Standard Days method
                                                                          –   TwoDay Method
                                                                          –   NFP
                                                                          –   Alone or in combination with, condom, Femidom, pessary, …..
                                                                          –   …………




Jacquemyn: Scientific basis


                                                                                                                                                        9
           Problems when studying FAM                                 Problems when studying FAM
            Mixture of methods                                         When using a standardized method, involving good
            Often combined with condom etc. on fertile days            training much better results are obtained
            Studies on contraception are always flawed: by the
            pharmaceutical industry, by religious authorities….        See: Petra Frank-Herrmann
            Motivation, training etc.

            Combining in a review all FAM is like combining
            bycicles, cars, and trains to calculate the travel time
            “on wheels”




                                                                      Conclusions

                                                                       FAM have a sound physiologic basis
                                                                       Calendar alone is useless
             Conclusions                                               Combination methods and training are necessary




Jacquemyn: Scientific basis


                                                                                                                          10
                                                                         Fertility Awareness based Methods (FAM)

   Petra Frank-Herrmann                                                    • Determination of the fertile window of
                                                                             the cycle by the woman herself

                                                                           • Couples use it
      Introduction into the Biomedical Aspects                               – to avoid a pregnancy
                    Awareness-
       of Fertility Awareness-based Methods                                  – to achieve a pregnancy
         Dpt. of Gynecological Endocrinology, University of Heidelberg




                                                                         Controversy
    Determination of the Fertile Window
                                                                           • Do Fertility Awareness based Methods
             main parameter:
                   parameter
                                                                             work?
             cervical mucus pattern
             temperature changes

     The cervical mucus as estrogen marker and
     the basal body temperature as progesterone
     marker represent the complete picture of the
     hormonal ovarian cycle.
                       cycle




Fertility Awareness based Methods (FAM)                                  Answer

  • Today:     FAM are still outsider methods with an                      • The German Arbeitsgruppe NFP started a
               ideological touch                                             subventioned project in the 80ie
  • However: from a medical point of view
                                                                             – studies on the scientific, physiologic basis of NFP
             FAM/NFP is just
             applied biological knowledge
                                                                             – development of a complete NFP methodology
                                                                                  • easy rules for the couple
  • Therefore: They work!                                                         • teaching skills for teachers
                                                                                  • teacher training course
  • Question: How precise do they work?
                                                                             – studies on the efficacy to avoid and to achieve a
                                                                               pregnancy (acc. to EBM criteria)



Fran-Herrmann: Biomedical Aspects
Contents                                                                                Contents

   • The common FAM method of the German                                                    • The common FAM method of the German
                        NFP-               NFP-
     Arbeitsgruppe NFP, NFP-Vlaanderen and NFP-                                                                  NFP-               NFP-
                                                                                              Arbeitsgruppe NFP, NFP-Vlaanderen and NFP-
                (NFP-
     Nederland (NFP-DAG*)                                                                                (NFP-
                                                                                              Nederland (NFP-DAG*)

   • Current FAM methodology to avoid pregnancy:                                            • Current FAM methodology to avoid pregnancy:
     what is effective and evidence-based?                                                    what is effective and evidence-based?

   • Further application in Gynaecology and Reproductive                                    • Further application in Gynaecology and Reproductive
     Medicine                                                                                 Medicine


       * NFP according to the Deutsche ArbeitsGruppe                                               * NFP according to the Deutsche ArbeitsGruppe




FAM-
FAM-methods                                                                             Efficacy

   • Temperature Methods/Calculation methods:                                                  maior issue in family planning choice
     no longer used as single indicator,
     except: Standard days method (SDM)                                                        in European countries

   • Cervical mucus methods
                     • Billings-Ovulation Method (OM)
                     • TwoDayMethod (TDM) = simplified mucus method                            representative public opinion poll
                                                                                               (Freundl 1985)
   • Symptothermal Method (STM)
                       double-                                      (NFP-
                     • double-check: onset and end of fertile phase (NFP-DAG)
                     • onset: mucus only, end: double-check




Quality criteria of STM-Development in Germany,
                    STM-                                                                Determination of the fertile phase
NFP-                   NFP-
NFP-Vlaanderen and NFP-Nederland                                                                              NFP-
                                                                                        according to the STM NFP-DAG
 • Decision-making only by Scientific Committee
                (acknowledged by the German Association of Obstetrics and Gynaecology
                as an expert group for „Natural Fertility“)
                                                                                                                                 ovulation
 • ST methodology: effective and evidence-based
                                                                                              1. Cervical mucus           whatever           1. Peak of the cervical     whatever
 • Practicability (only necessary rules)                                                      2. Earliest temperature      comes                mucus symptom plus 3      comes
                                                                                                 rise out of 12 preceding   first            2. Third higher temperature   last
 • Standardized teaching materials (NFP-DAG)                                                     cycles minus 8                                 reading


 • Standardized teacher training courses with permanent evaluation

                                                                                        Bleeding                                                                       Bleeding
                                                                                                                                                                       Bleeding
 • Own Database to study NFP use (EBM – peer reviewed)                                  Bleeding
                                                                                                          Onset of the                             End of the
                                                                                                         fertile window                          fertile window
 • Continuous systematic review of international research (>1500
   references)



Fran-Herrmann: Biomedical Aspects
To get interpretable cycle charts:

    • Chart should allow documentation of
                                                                                                                                   Temperature observations
                  • different symtoms
                  • the time of temperature measurement
                  • and disturbances


    • Disturbed temperatures have to be excluded

    • Use of a suitable thermometer
                                                                                                                                       Mucus observations
    • Observation of the cervical mucus externally (!) at the
      vulva                                                                                                                           Cervix observations




                                              e.g. travel, illness,
                                              shift services,…                                   The cycles are numbered




                                                                                                   The way of measure-
                       Start measuring temperature                                                 ment indicated
                       1st day of menstruation




                                                  Indicate temperatures by dots,
                                                  link following temperatures to
                                                  each other; missing ones are
                   The 1st day of the                                                                  The 1st higher
                                                  left open
  Note the date    bleeding is the 1st                                                                 temperature is
                   cycle day                                                                           written down




                                                     Daily charting mucus
                                                     observations at the
                                                     evening

     Indicate amount                                                               The beginning of
     of bleeding                         Daily charting the                        menstruation is charted and
                                         cervix observations                       a new chart taken


                                                Noting the fertile
                                                days




                                                                                                                                    NFP-
                                                                                                                           Learning NFP-DAG

                                                                                                                             • NFP is as driving a car.
                                                                                                                             • Once the client has learned it, it
                                                                                                                               becomes a second nature…
                                                                                                                             • … ideally, it is learned out of a book and
                                                                                                                               by an experienced instructor.




Fran-Herrmann: Biomedical Aspects
         NFP-
Learning NFP-DAG                                                      Contents

  • User: 4 x 2 hours (3 cycles)
    User                                                                • The common FAB method of the German
      – individualized teaching                                           Arbeitsgruppe NFP, NFP-Vlaanderen and NFP-
                                                                          Nederland (NFP-DAG)
      – A few minutes a day (observation and charting)
      – Until end fertile phase
                                                                        • Current FAB methodology to avoid pregnancy:
                                                                          what is effective and evidence-based?
  • Teacher:
    Teacher
      – 50 hours teacher training course                                • Further application in Gynaecology and Reproductive
      – Practice (3 couples)                                              Medicine
      – Yearly accreditation




NFP-
NFP-methods today                                                     NFP-
                                                                      NFP-methods today

  •   still „too“ many variations of methodology
             too“                                                       BUT
                                                                        • Each target group has different expectations
  • often historically grown                                               – Europe: high efficacy – child wish
                                                                           – Third world: spacing – child wish
  • lack of scientific selection/rejection of rules                     • Each target group has his own possibilities
                                                                           – Europe: hight tech
                                                                           – Third world: no technical help
  • controversial discussion of effectiveness
                                                                            Each method has his own target group




Effectiveness of the end of fertile phase
                                                                      Beginning of fertile phase: mucus only
by TM/STM
  TM     retrospective studies     (method-related pregnancy rates)     Prospective studies             Method effectiveness
                 • Vincent 1967 (0.1)
                 • Döring 1967 (0)
                                                                        Ball 1976 (OM)                  2.9 (all on dry days)
         prospective studies
                 • Marshall 1968 (1.2)                                  Klaus et al. 1979 (OM)          1.0 (most on dry days)
                 • Vollman 1975 (0)                                     Johnston et al. 1978 (STM/OM)   3.7-9.8 (all on dry days)
                 • Rice et al. 1977 (0.2)
                                                                        WHO 1981 (OM)
  STM    retrospective studies
                 • Rötzer 1968 and 1978 (0)                               Ireland                       3.4
         prospective studies                                              Newseeland                    6.3
                 •   Johnston et al. 1978
                                                                        Barbato et al. 1988 (STM)       All 12 method-related
                 •   Barbato and Bertolotti 1986 (0)
                                                                                                        pregnancies when
                 •   Frank-Herrmann et al. 1991 and 1997 (0)
                                                                                                        preovulatory only mucus
                 •   European Multicenter Study 1993 (0)
                                                                                                        observation



Fran-Herrmann: Biomedical Aspects
Beginning of fertile phase:
                                                                     RCT‘
                                                                   2 RCT‘s (randomized controlled trials)
Döring rule, shortest cycle rule
                                                                      •   Grimes et al. Cochrane Database Syst Rev. 2004 Oct 18; (4): CD004860
  Prospective studies
                                                                      Los Angeles-Study: Wade et al. (1981) Am J Obstet Gynecol 141:368-376
                                                                      Columbia-Study: Medina et al. (1980) Am J Obstet Gynecol 138:1142-1147
  •Vollman 1975 (minus 20, 12 cycles)                0.1
                                                                      •   Both RCT‘s completely failed (major drop out because of lack of
  •Rice 1981 (-19,-20,12 cycles, -21, 6 cycles)      0.5                  motivation of the users)
  •European Study (double-check)                     0
                                                                      •   RCT‘s to compare STM and Mucus methods are not possible, because
  •German Database 1997, 2007 (double-check)         0.2                  the expected outcome is not equal (equipoise)

                                                                      •   RCT‘s to compare different categories of family planning methods are
                                                                          not possible (f.e. NFP vs. oral contraceptives), because it is demanded
        Double check, 12 cycles minus 8 or 5 days!                        that there is no preference of users

                                                                      •   There are high quality prospective observational and longitudinal cohort
                                                                          studies (not mentioned in the Cochrane Database Syst. Review)




Population Surveys                                                 Efficiency: prospective studies
  e.g. National Survey of Family Growth (USA)
                                                                    Study            Women Cycles              UP       Method             User      Negative
  • at the moment not suitable to estimate the                      prospective                                         failure           failure    dropout
    effectiveness of NFP methods, because of two
    limitations:                                                    Döring                 291       3 370          5       0.7                2.0
     – the most effective NFP method (STM) is not mentioned in      1988
       the questionnaires
     – outdated and ineffective methods are mentioned and
       counted as NFP methods                                       Freundl             1 046      16 865        34         0.5                2.6      3.9
                                                                    1995
  • Interesting approach for the future!
                                                                    Frank-                 900     17 638        22         0.4                1.8      9.2
                                                                    Herrmann
                                                                    2007




Study                                                                                             (NFP-
                                                                   German STM effectiveness study (NFP-DAG)
                                                                      •   900 NFP beginners, 17.638 cycles (collected prospectively)
                                                                      •   19 – 45 years of age
      P. Frank-Herrmann, J. Heil, C. Gnoth, E. Toledo, S. Baur,       •   no postpartum, no breastfeeding, no postpill
      C. Pyper, E. Jenetzki, T. Strowitzki, G. Freundl                •   cycle length 22-35 days (80 % of the cycles of a woman)

      The effectiveness of a fertility awareness based method to      •   63 % < 30 years
      avoid pregnancy in relation to a couple‘s sexual behaviour      •   52 % no child
      during the fertile time:
                                                                      •   81 % spacer
      a prospective longitudinal study
                                                                      •   64 % medium level of education

   Human Reproduction 2007, 22(5):1310-1319                           • the option achieve or avoid pregnancy was clear
                                                                      • lost-to-follow-up rate = 6,3% after 13 cycles




Fran-Herrmann: Biomedical Aspects
                                                             Pregnancy rates in relation to perfect and
Measures of effectiveness
                                                             imperfect use
    Use-effectiveness                                          Sexual behavior in        Cycles       Cycles (%)   Unintended        Pregnancy rate   95% CI;    95% CI;
                                                               the fertile phase          (n)                      pregnancies (n)                    lower      upper
    • Life-table / Kaplan-Meier (actuarial curve)              Abstinence                6022         34,1         2                 0,43             0,05       1,55

      acc. to Tietze, Potter et al.
                                                               Protected                 4375         24,8         2                 0,59             0,07       2,13
                                                               intercourse

                                                               Unprotected               2353         13,3         14                7,46             4,15       12,23
                                                               intercourse
    Method-effectiveness                                       Protected and             1183         6,7          2                 2,18             0,27       7,66
                                                               unprotected
    • Perfect/imperfect use-approach                           intercourse
                                                               Genital contact           1080         6,1          1                 1,2              0,03       6,5
      acc. to Trussel and Grummer-Strawn
                                                               Not to classify           2625         14,9         1                 0,49             0,01       2,72


                                                               total                     17638        100          22                1,62             1          2,43
    (no parametric models)

                                                                                                 Frank-Herrmann P et al., Hum Rep, 2007




Contents                                                      NFP to achieve a pregnancy
  • The common FAB method of the German
    Arbeitsgruppe NFP, NFP-Vlaanderen and NFP-
    Nederland (NFP-DAG)

  • Current FAB methodology to avoid pregnancy:
    what is effective and evidence-based?

  • Further application in Gynaecology and Reproductive
    Medicine




                                                                                   Infertility study at the University of Heidelberg
NFP meets Gynaecological Endocrinology


             Infertility                                                                                                                                        The infertility
             Hormonal disorders                                                                                                                                 patient
                        hyperprolactinemia                                                                                                                      determines
                        hyperandrogenemia (adrenal)                                                                                                             the day for
                        polycystic ovaries syndrome (PCOS)                                                                                                      the diagnostic
                        postpill amenorrhea                                                                                                                     measures
                        amenorrhea after eating disorders
                                                                                                                                                                (ultrasound,
                        endometriosis
                        premenopause
                                                                                                                                                                blood
                        POF (premature ovarian failure)                                                                                                         sample,
                                                                                 E2                   212                                                       postcoital
             dysmenorrhea
             contraindication for oral contraceptives                            LH                    65                                                       test) herself
             thrombophilie                                                       Prog.                1,3                                                       acc.to her
             mikromosaic Turner                                                                                                                                 observations
                                                                                 Follikel              19
             etc.




Fran-Herrmann: Biomedical Aspects
           Infertility study at the University of Heidelberg
                                                                     NFP-
                                                                     NFP-teaching in Gynecological Endocrinology

                                                                       1. Avoiding pregnancy:
                                                                              symptothermal method with complete
                                                                              methodology
                                                      Luteal blood     2. Trying for pregnancy / infertility
                                                      sample on
                                                      day 7 of                cervical mucus and temperature charting, peak
                                                      elevated                fertility, sexual behavior
                                                      temperature
                      E2       89                                      3. Hormonal disorders / Oligo-Amenorrhea
                      LH      3,6
                                                                              cervical mucus observation, bleedings,
                      Prog     15
                                                                              temperature charting during mucus phases + 4
                      .
                                                                              days afterwards




                                                                     Take home messages I


                                                                       • Women/couples are able to develop a high
                                                                         degree of reproductive competence

                                                                       • Effective family planning is possible without
                                                                         medical intervention
                 Take home messages
                                                                       • Women/couples have a right to get informed
                                                                         about effective FAM informed choice /
                                                                         cafeteria approach




Take home messages II                                                Take home messages III
  The Symptothermal Method (NFP-DAG*)                                  Gynaecologists may use FAM / NFP-DAG much more
                                                                         than is currently the case:
  • is the recommended FAM for our countries
                                                                          – method of family planning for motivated couples
                                                                          – management of infertility
    double-
  • double-check to determine the beginning and the end of                – greater efficacy of diagnostic tests (hormones, US)
                         no
    the fertile window (no STM with mucus only to determine
                                                                          – assessment of degree and development of
    the onset of fertile phase)                                             hormonal disorders (extent of ovarian
                                                                            insufficiency)
  • low pregnancy rate with correct use                                   – better involvement of patient and her partner

  • can be as effective as oral contraception




Fran-Herrmann: Biomedical Aspects
Take home messages IV

    FAM has to be taught
      at university level and
      to midwives, GP and ObGyn

    = clinical decision making

                                    Thank you very much for your attention




Fran-Herrmann: Biomedical Aspects

								
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