Q from U: Can I use frozen donor eggs from a friend?

June 26, 2013Carole No Comments »

I received this question via email recently: We have a friend who has frozen eggs and wants to donate them to us, the issue is that the eggs were originally for her and her husbands use so they did not do FDA testing as it was not required. The eggs are from 2009 I believe.  Do you know any way around the FDA guidelines so that we could use these eggs?”

I responded to the patient privately but thought that others might have the same question. With the FDA, their donor eligibility rules will vary somewhat depending on the type of donated tissue (eggs, sperm or embryos) and whether the “donation” occurs between sexually intimate people (no testing required) or anonymous donation (all testing is required) or not intimate but known to one another as friends or family (directed donation)  and whether the sample is donated fresh or stored frozen after a period of quarantine.

My response to the emailed question is below. I would welcome any insight from any attorneys out there who specialize in reproductive law and/or FDA regulations who might be able to add their expert opinion.

Thanks for your question. It is a good one. Here’s a link to an FDA site FAQs page that lists the tests that donors must undergo to donate either eggs or sperm. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm232876.htm

First, sometimes patients say eggs when they mean embryos. If your friends actually have frozen embryos (fertilized eggs or eggs that divided to embryo stage)  to donate, it is actually pretty easy. Because of the prevailing political winds of the time (President George W Bush) was in office, embryo donation was favored as a part of the Pro-life movement and a special exemption was put in the law that allowed embryos to be donated without strict adherence to the testing rules, required by the FDA for gamete donations. In fact, if the couple donating an embryo couldn’t or wouldn’t do the donor eligibility  testing, the FDA looked the other way, and just required that the program explain to the recipient what testing they in effect declined by accepting the embryos and what risks they undergo- see labeling requirements below.

Risks of disease transmission were (and are) considered negligible by the majority of IVF practitioners because we don’t have any scientific evidence of embryos (or eggs) carrying bacterial or viral infection that is then passed on to the receiving woman. Sperm, because of the number of cells and the associated fluids, do present a potential risk of STDs through intercourse, and possibly, in spite of required washing steps,  even with IVF/ICSI.

Exceptions to the FDA  testing/screening rules are listed here. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.90 and copied belowmy comments are in bold

Sec. 1271.90 Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply?

 

(a)Donor-eligibility determination not required . You are not required to make a donor-eligibility determination under 1271.50 or to perform donor screening or testing under 1271.75, 1271.80 and 1271.85 for:(1) Cells and tissues for autologous use; or (Not applicable to your case)

(2) Reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use; or (this exemption applies to your friends, why they were not tested when the eggs were for their own use)

(3) Cryopreserved cells or tissue for reproductive use, other than embryos, originally exempt under paragraphs (a)(1) or (a)(2) of this section at the time of donation, that are subsequently intended for directed donation, provided that  (This may apply to your case)

(i) Additional donations are unavailable, for example, due to the infertility or health of a donor of the cryopreserved reproductive cells or tissue; and  (if your friends were unable to produce new eggs for your use that could go through the screening process- you might be able to use this exemption. I am not sure who decides whether “health of donor” is an issue. Physician may be able to waive it on this basis)

(ii) Appropriate measures are taken to screen and test the donor(s) before transfer to the recipient. (And your friends would probably have to agree to submit to testing at this late date. If all the female’s tests are still negative(in the case of donated eggs) – you might be good to go)

(4) A cryopreserved embryo, originally exempt under paragraph (a)(2) of this section at the time of cryopreservation, that is subsequently intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient. (Here is the easier path for embryo donation– see “when possible” screen donors otherwise whatever- but be sure to do labeling procedures below!!)

(b)Required labeling . As applicable, you must prominently label an HCT/P described in paragraph (a) of this section as follows:

(1) “FOR AUTOLOGOUS USE ONLY,” if it is stored for autologous use.

(2) “NOT EVALUATED FOR INFECTIOUS SUBSTANCES,” unless you have performed all otherwise applicable screening and testing under 1271.75, 1271.80, and 1271.85. This paragraph does not apply to reproductive cells or tissue labeled in accordance with paragraph (b)(6) of this section.

(3) Unless the HCT/P is for autologous use only, “WARNING: Advise recipient of communicable disease risks,”

(i) When the donor-eligibility determination under 1271.50(a) is not performed or is not completed; or

(ii) If the results of any screening or testing performed indicate:

(A) The presence of relevant communicable disease agents and/or

(B) Risk factors for or clinical evidence of relevant communicable disease agents or diseases.

(4) With the Biohazard legend shown in 1271.3(h), if the results of any screening or testing performed indicate:

(i) The presence of relevant communicable disease agents and/or

(ii) Risk factors for or clinical evidence of relevant communicable disease agents or diseases.

(5) “WARNING: Reactive test results for (name of disease agent or disease),” in the case of reactive test results.

(6) “Advise recipient that screening and testing of the donor(s) were not performed at the time of cryopreservation of the reproductive cells or tissue, but have been performed subsequently,” for paragraphs (a)(3) or (a)(4) of this section.

[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005]

Section 3I and 3ii may apply to your case of egg donation. You’ll need to find a physician who is willing to work with you on this because he ( I think,  based on my understanding) has to document that no other path was available for you to get previously tested donor eggs  (the usual requirements for fresh egg donation could then be waived) or only follow-up testing required. Your friends might have to consent to be re-tested and so you might have to pay those costs too. Again, easier to donate without screening if it is donor embryos, not gametes.

Also, make sure that– if it is truly eggs we are talking about- that your IVF lab has a very good track record with using frozen eggs (thawing can be tricky). In 2009, slow freezing protocols were probably more common than vitrification protocols.  If the eggs were slow-frozen vs. vitrified, they are more likely not to thaw well. With the old slow freeze method, we were happy if even 50% of embryos survived intact- the success rate was even less with eggs. With vitrification, the successful thaw and use of eggs became much more doable with many good programs reporting pregnancy rates as good as fresh with frozen eggs. But not all programs are equally good at using vitrification. Ask for pregnancy rates and experience with using frozen eggs.

I am neither an attorney or an MD, so please discuss your plan and the FDA regs with your doctor before you proceed. Good Luck!!

© 2013, Carole. All rights reserved.

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