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THE ALLIANCE OF ETHICS AND INNOVATION

ETHIEK IN DE FERTILITEITSKLINIEK VROEGER EN NU. THE ALLIANCE OF ETHICS AND INNOVATION. Prof Dr P Devroey. Vroeger (vóór 1978). Ovulatie inductie Meerlingen? OHSS? Fertiliteitchirurgie macro - micro Niet succesvol? Onnodige ingrepen? Husband inseminatie

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THE ALLIANCE OF ETHICS AND INNOVATION

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  1. ETHIEK IN DE FERTILITEITSKLINIEK VROEGER EN NU THE ALLIANCE OF ETHICS AND INNOVATION Prof Dr P Devroey

  2. Vroeger (vóór 1978) • Ovulatie inductie • Meerlingen? • OHSS? • Fertiliteitchirurgie macro - micro • Niet succesvol? • Onnodige ingrepen? • Husband inseminatie • Efficiëntie? • Donor inseminatie ???

  3. Innovation: the act of introducing “new” • Why innovation? • To improve? • Ethics: moral science studying the principle of right and wrong in human conduct • Who will decide? • Based on?

  4. Layman ethicus • Professionele ethicus • Verticale ethiek gebaseerd op een filosofisch dictaat • Horizontale ethiek gebaseerd op rationele kennis

  5. Waarom innovatie ? • To improve the human condition • Intracytoplasmic sperm injection (ICSI) Palermo Devroey Joris Van Steirteghem Lancet 1992

  6. ICSI EVALUATIE • Behandeling op celniveau • Geëjaculeerd sperma • Testiculair sperma • Wereldwijd toegepast • Miljoenen kinderen • Safety van de kinderen

  7. HOW CAN WE HANDLE “ETHICS” ? • Niveau 1 • Wetenschappelijke evidentie gebaseerd op peer reviewed gepubliceerde gegevens • Niveau 2 • Academische evaluatie m b t psychologie, veiligheid, juridische kennis, ethische kennis • Niveau 3 • Aanvaarding op niveau van culturen en filosofieën

  8. EVIDENCE BASED MEDICINE • Hoe de evidence bewijzen (mechaniek) • Randomized controlled trials • Een duidelijke vraagstelling • Sample size • Eén variabele • Publicatie

  9. PREIMPLANTATIE GENETISCHE SCREENING

  10. PGS wordt frequent uitgevoerd • ESHRE Consortium (Harper HR 2006) • 1997 - 2001 1990 cycli • 2002 1211 cycli

  11. ADVANCED MATERNAL AGE - GENETIC EVIDENCE • Incidence of aneuploidy  with age Due to the  aneuploidy rate  implantation rate  and miscarriage rate  • Estimates of live birth rates with trisomy XY, 13, 18, 21 (Hook et al 1981) Age • 37 years : 0.8 % • 40 years : 1.6 % • 43 years : 3.3 % • 46 years : 6.9 %

  12. Round 2 : 16q11.2 Orange 22q11.2 Green Round 1 : Xp11.1-q11.1 Blue Yp11.1-q11.1 Gold 13q14 Red 18p11.1-q11.1 Aqua 21q22.13-q22.2 Green

  13. AMA % ABNORMAL EMBRYOS

  14. EFFECTIVENESS OF PGS AMA - COMPARATIVE STUDIES

  15. RANDOMIZED CONTROLLED TRIAL UZ BRUSSEL • Couples with ≥ 37 years of maternal age • Day 5 transfer of compacting and blastocyst stage embryos with or without PGS Staessen et al (2004) Hum Reprod 19 2849 - 2858

  16. Control PGD-AS ICSI / G1-G2 medium DAY 0 DAY 3 biopsy (if embryos reaching3rd mitotic division) FISH  1st round (XY,13,18,21) DAY 4 FISH  2nd round (16,22) DAY 5 if blastocyst if genetically normal and at blastocyst stage ET

  17. METHODS • Biopsy : removal of 1 blastomere • Probes : XY, 13, 16, 18, 21, 22 • One blastocyst transferred on day 5

  18. CHARACTERISTICS OF THE PATIENTS T-test : no statistical differences

  19. RCT : ADVANCED MATERNAL AGE (≥ 37 Y) Staessen et al. (2004) Hum Reprod, 19, 2849-2858 *: t-test: p<0.01

  20. RCT - PGS - SET • Delivery rate is primary endpoint • Replacement of one blastocyst • Day 5 without PGS versus • Day 5 with PGS • Sperm ≥ 1.000.000 / CC • Normal karyotype for both partners Brussels, Centre for Reproductive Medicine

  21. CLINICAL OUTCOME *not statistical different

  22. CLINICAL OUTCOME

  23. Do globally applied ethics exist ? • No • Are the European laws on reproduction similar or different ? • Different • Are democratic rules on ethics applicable ? • No

  24. DO GLOBALLY APPLIED ETHICS EXIST ? • No • The Jews of Paris and New York have the same ethics , same decision making process • The Catholics of Manila and Rome have ethics , same decision making process

  25. ARE THE EUROPEAN LAWS DIFFERENT OR SIMILAR ?DIFFERENT

  26. ARE DEMOCRATIC RULES IN PRINCIPLE APPLICABLE ON ETHICS ? NO • Democratic rules decide on “law” making per definition • In principle democratic rules are not applicable on ethics • Moslem religion does not accept egg donation (60 % of the members of the Parliament) • Jewish religion does accept egg donation (40 % of the members of the Parliament) • Conclusion : in a given country the law will forbid egg donation

  27. SAVIOUR BABIES • A child suffers from thalassemia and will die • Preimplantation offers hLA typing and the use of cord serum can / will save the sick child and the newborn will be disease free • Decision • After psychological evaluation • No PGD and IVF (the child dies) • PGS and IVF (the child survives)

  28. CODA • Innovation is mandatory • Vertical ethics overrules horizontal decision making • Democratic voting overrules ethical decision making • European laws are all different and initiates cross border care (medical tourism) • Evidence based medicine is a key player

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