Scientific and Ethical Issues in Assisted Reproduction

1. Scientific and Ethical Issues in Assisted Reproduction Judy E. Stern, PhD Department of Ob/gyn Dartmouth-Hitchcock Medical Center

2. AZ vs. BZA case involving frozen embryos • History of the couple. The husband and wife were married in 1977. …. resided in Virginia…. • Encountered … difficulties conceiving a child and underwent fertility testing. … suffered an ectopic pregnancy…. miscarried … • In 1980, the husband and wife moved to Maryland where they underwent additional fertility treatment…. did not result in a pregnancy. • In 1988, the wife…transferred to Massachusetts and the husband remained in Maryland … After arriving in Massachusetts, the wife began IVF treatments … At first the husband traveled from Maryland to participate in the treatments. In 1991, he moved to Massachusetts.

3. AZ vs. BZ • Given their medical history, the husband and wife were eligible…..for IVF • injecting the woman with fertility drugs • eggs harvested • combined with sperm • preembryos are formed and either transferred or frozen

4. ART Process • Hormones to produce multiple eggs • Retrieval of eggs • Add sperm to eggs (Insemination or ICSI) • In vitro culture • Embryo transfer

5. AZ vs. BZ • Given their medical history, the husband and wife were eligible…..for IVF • injecting the woman with fertility drugs • eggs harvested • combined with sperm • preembryos are formed and either transferred or frozen • IVF treatment from 1988 through 1991. As a result of the 1991 treatment, the wife conceived and gave birth to twin daughters in 1992. • During the 1991 IVF treatment… two vials of preembryos were frozen

6. Embryo freezing • Add cryopreservative • Slow freeze to -30ºC or -37ºC • Plunge in LN2 -196ºC • Embryos can survive indefinitely in LN2 • To thaw- remove from LN2 and remove cryopreservative Straws or vials

8. AZ vs. BZ • In the spring of 1995, before the couple separated, the wife desired more children and had one of the remaining vials of preembryos thawed and one preembryo was implanted. She did so without informing her husband. • The husband learned of this when he received a notice from his insurance company regarding the procedure. • During this period relations between the husband and wife deteriorated. The wife sought and received a protective order against the husband ….. Ultimately, they separated and the husband filed for divorce.

9. AZ vs. BZ • At the time of the divorce, one vial containing four frozen preembryos remained in storage at the clinic • The consent form on file for this couple stated that if they were to divorce the embryos should go to the wife to establish pregnancy. • Nevertheless, the husband filed a motion to obtain a permanent injunction, prohibiting the wife from "using the remaining vial of frozen preembryos.

10. AZ vs. BZ • Question for the appellate court.. Should the wife be allowed to thaw the embryos and use them? • What are the issues in this case?

11. B i o N e w s 243 Week 26/1/2004 - 1/2/2004 Rokitansky Syndrome Case 1 • Lata Nagla, a 26-year old Indian woman has Rokitansky syndrome, a rare congenital condition where the uterus does not develop normally. ….she is unable to carry or give birth to her own children. • However, she has normally functioning ovaries and is able to produce eggs to be used in IVF treatment with her husband's sperm, creating embryos that could be transferred and gestated in another woman’s womb.

12. B i o N e w s 243 Week 26/1/2004 - 1/2/2004 Rokitansky Syndrome Case 2 • The couple looked into fertility treatments in the UK when they first found that they had problems conceiving….once it was discovered that the woman's womb was absent…the couple looked for a woman to act as a surrogate for them - in both the UK and in India - with no luck. • They then approached Dr Nayana Patel, an Indian fertility expert, who suggested that the woman could ask her own mother to be the surrogate……………..

13. Types of Surrogacy • Traditional surrogacy • Gestational surrogacy His sperm Surrogate’s egg and uterus ART Embryo His sperm + Her eggs Surrogate’s uterus

14. A grandmother has given birth to her own daughter's IVF twins. • A 43-year old grandmother has given birth to her own daughter's IVF twins.

15. Rokitansky Syndrome Case • Are there ethical, legal, or social concerns raised by this case?

16. ASRM News Winter 2002 (Susan Crockin Esq)Case of Daniel B1 • A California case is pending over the custody of a child born over a year and a half ago to a single woman [Susan B] who thought she had achieved her IVF pregnancy using anonymous donor egg and donor sperm. • The pregnancy was apparently the inadvertent result of an embryo transfer from the same group of embryos created by a married couple [Robert and Denise], who had used donor egg and husband sperm and who where cycling at the same time. • That couple gave birth to a girl; the single woman to a boy.

17. ASRM News Winter 2002 (Susan Crockin Esq)Case of Daniel B2 • Parents became aware of the mix-up when the children were almost a year old. • An anonymous letter sent to the state …. medical board investigation • With the doctor’s encouragement, the three patients met in January in an unsuccessful attempt to work out an informal resolution. • A month later the married couple sued the single woman for custody…...the single woman has since sued the medical program for malpractice……

18. Are there issues to be considered in this case? • How would you decide custody?

19. Follow up ASRM Newsletter 2002 (Susan Crockin Esq)Case of Daniel B (Court Decision1) • Two mothers were one too many, and no father was one too few, for an appellate court asked to determine parentage of a child born through an embryo mix-up….. • The court ruled that Robert could not be characterized as a “donor” within the meaning of California’s donor statute, because he did not intend to inseminate anyone other than his wife

20. Follow up ASRM Newsletter 2002 (Susan Crockin Esq)Case of Daniel B (Court Decision2) • …and that Susan’s claim of a right to sole parentage was better suited to the legislature; and that any constitutional claims on behalf of Daniel to a “stable, permanent placement” was an argument for future potential custody claim by the father and his wife. • The court also rejected the wife’s arguments, ruling she lacked standing under California law because she has not biological relation to the child…..

21. Who should make decisions about the use of ART? • Patients? • ART clinics? • Courts? • Legislature?

22. Case Scenario1A couple in which the woman is 27, is undergoing IVF at your clinic. They state up front that they very much want to establish a pregnancy and that to do this they would like to have at least 6 embryos transferred in this cycle. After much discussion, the couple feel strongly that they would like this done even though they understand the risks of multiple pregnancy. They agree to sign a waver absolving the clinic of any liability for the risks assumed.Will you transfer 6 embryo to this couple?

23. Case Scenario 2 A couple has undergone IVF at your clinic. They have conceived twins. You had discussed the risks of multiple pregnancy. They cannot find a physician willing to reduce this to a singleton pregnancy, so they decide to abort both fetuses. The couple returns to your clinic to undergo IVF again in hopes that they will have a singleton the next time.Will you perform IVF for this couple?

24. PGDRemoval of cells for diagnosis