New FDA regulations will hurt egg and embryo donation

New FDA regulations will hurt egg and embryo donation

Last update / published 05/13/2005

On May 25, 2005, new FDA guidelines for the donation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), will go into effect. Reproductive tissue such as sperm, eggs and embryos will be affected by these testing guidelines.

Sperm which are frozen and quarantined for several months already will not be adverseley affected. However, eggs, which are currently donated “fresh” (egg donation) and embryos that are designated for cryopreservation will be significantly affected.

7-Day Testing Requirement

The new FDA guidelines require donor testing for a number of communicable diseases such as HIV (AIDS) and hepatitis “seven days prior to (oocyte) egg retrieval“. This 7-day window poses a large problem. Most women who are taking fertility medications for in vitro fertilization – IVF cycles need 9 to 10 days before the hCG trigger injection. The (oocyte) egg retrieval follows two days later. The same time course applies to egg donors. The practical consequence of this rule is that if an infectious disease test turns up positive, then the treatment must be cancelled after the woman has already started stimulation of her eggs with the very expensive gonadotropin medications. This significantly increases the cost for the recipient and causes the egg donor to have to undergo several days of injections needlessly.

Furthermore, there doesn’t seem to be any medical data that backs up the 7 day choice. In New York State, for example, they have a thirty day rule and have not had any problems.

The Effect on Embryo Donation

Couples may decide to donate embryos at two different time points: before the start of their own in vitro fertilization – IVF cycle or months or years afterward as they are deciding the disposition of their extra embryos.

The new rules mandate that couples who are interested in Embryo Donation must also have the infectious diesase testing 7 days before retrieval. If they do not have this testing, they will not be able to donate embryos now or later.

We can understand the FDA has a desire to protect the public health but these rules clearly demonstrate a lack of understanding of how reproductive tissues are used and the logistics involved. A more logical approach would be to use the 30 day rule or to simply state that the testing must be completed before the stimulation of the ovaries has started.

There is an exception to the FDA rules for infectious diseased testing. If the donation is going to a known donor, the couple is exempt from testing. However, several questions are as yet unanswered. For example, when must the donating couple “know” the recipient? Do they have to know her before the original IVF cycle? Or if they use an agency such as “Snowflakes” where donors and recipients can meet well after the IVF cycle, is that sufficient to meet the requirement for an exemption? What if the female partner dies and the male wants to use the embryos with a gestational carrier or new partner? In this case, he will know the recipient but the female, who has died won’t.

A lot of issues need to be worked out here. The FDA will need to be flexible in accomodating for the special needs of donating reproductive tissues.