A Call to Protect the Health of Women Who Donate Their Eggs

Article taken from page 4 and 5 of the November/December Newsletter 2016

The egg market is growing. As couples and individuals continue to rely on assisted reproductive technology to overcome infertility, to make parenthood possible for gay people, and for other reasons, the demand for eggs is increasing swiftly.1 Between 2000 and 2010, the number of donor eggs used for in vitro fertilization increased about 70 percent, from 10,801 to 18,306, according to a report in the Journal of the American Medical Association (JAMA).2

And, although there are no exact figures for how many young women engage in egg-retrieval-for-pay, the numbers are at least in the thousands. Many of these women are in their early 20s —and are often university students who need cash to cover their tuition fees.3 But, most people don’t realize that there are no good long-term safety data that would enable these young women to make truly informed choices about selling their eggs.

Now, a number of women’s health and public interest advocacy organizations — including Our Bodies Ourselves, the Pro-Choice Alliance for Screen Shot 2016-11-12 at 8.52.00 AM
Responsible Research, and the Center for Genetics and Society — are studying women’s knowledge about egg retrieval and calling for more and better research about its risks.4

What we are finding is that women often know too little about the egg donation process and potential risks. Here’s an example: One drug frequently used to suppress ovarian function is leuprolide acetate (Lupron).5 The U.S. Food and Drug Administration (FDA) has not given approval for this particular use of the drug (Lupron is approved as a treatment for endometriosis, fibroids, early puberty and prostate cancer). So, it is used during egg retrieval protocols through “off label” use. In various surveys of younger women who are donating their eggs, it appears that this fact about off-label use is rarely shared. Probably few, if any, of these young women know about the 300-page review of many Lupron studies that Dr. David Redwine submitted to the FDA in 2011. In this report, he documents a plethora of problems, many serious, and some long-term.6

These problems include subsequent infertility, a possible link to certain cancers, and more prevalent short-term problems with Ovarian Hyperstimulation Syndrome (OHSS) than previously reported in the literature. Given the strong anecdotal evidence of such problems, more well-done studies are critically needed.

How can we encourage the collection of adequate long-term data about the extent and severity of egg retrieval risks? There’s one independent voluntary national registry in the U.S., the Infertility Family Research Registry (IFRR), based at Dartmouth-Hitchcock Medical Center in New Hampshire. But, very few large fertility centers are even willing to put out the brochures and placard for the IFRR. (See www.ifrr-registry.org.)

In the absence of prospective clinical trials that follow women over a long time to assess egg donation’s risks, the IFRR is one of the few ways we can track women to determine the longer-term dangers. We hope this situation will change soon, but that’s only likely if a large number of egg donors start demanding this is assessed, and that clinics make young women aware of the registry’s existence. Find out what you can do here.

Ironically, many of the fertility centers that don’t make those brochures available in their waiting areas are members of the American Society for Reproductive Medicine (ASRM), the professional organization of fertility practitioners that has provided modest grant support to the IFRR.

To address the situation, in early 2013, three young women formed “We Are Egg Donors,” the first-ever self-help advocacy group created by women who have provided eggs (www.weareeggdonors.com). These women have been collaborating with Diane Tober, PhD, at the University of California, San Francisco (UCSF) to conduct in-depth interviews with other women who have provided their eggs and systematically collect information about a full range of their experiences, from emotional to physical (see http://eggdonorresearch.org). They join other women’s health and public interest advocacy organizations that are studying women’s knowledge about egg retrieval, calling for more research, and encouraging greater participation in the IFRR.

Raquel Cool, a founding member of We Are Egg Donors, says that the U.S is “among the only countries in the world where eggs are freely and openly exchanged for uncapped amounts.” She continues, “I recall one member’s experience, a first-time donor, whose reproductive endocrinologist deemed her at a high risk of Ovarian Hyperstimulation Syndrome. He canceled the cycle. I’ve seen that happen once in three years. More often, we regularly see cases of OHSS, a fully preventable condition where, in severe cases, the [egg] provider’s abdomen swells with fluid and needs to be drained with a needle, or can cause a stroke. Collecting safety data — both of the short- and long-term risks — can only support informed choice.”

Dr. Tober, who is also producing “The Perfect Donor,” a film about egg donation, notes that “there is a great deal of inconsistency in how egg donors are treated, both in their interactions at clinics and agencies and medically.” She continues, “While some physicians are more conservative with the medical protocols, others use very aggressive protocols and end up with excessive numbers of eggs in their donors. Even though some women do naturally produce more eggs than others, the number of mature oocytes produced can be somewhat controlled by using more conservative medication dosages. Some insurance companies are also now refusing to insure physicians with high OHSS rates in their donors, but this information is not being made available beyond those in the industry. Doctors are thus far not held accountable when a donor has severe complications.”

A 2013 editorial in JAMA noted that “more complete data on both short- and long-term outcomes of donation are needed so donors can make truly informed choices and, once those data are available, mechanisms can be put in place to ensure that the donor recruitment and consent process at clinics is conducted according to the highest ethical standards.”7

A 2014 statement by the National Perinatal Association recommends that: “State regulatory agencies who license and provide oversight for collection and use of human tissues should provide the same level of oversight for sperm banks, the selling of human eggs and egg ‘donation.’ ”

We agree with the 2007 New England Journal of Medicine article that said, “If women are going to donate eggs, we must ensure that their health is not compromised. We need, therefore, to subject egg donation to far more scientific scrutiny than it currently receives. We need more longitudinal studies of the drugs involved in ovarian hyper-stimulation, for example, more long-term follow-up of egg donors, and deeper analyses of the conditions under which dangerous complications occur.”8

Jennifer Schneider, M.D., a Tucson-based internist whose own daughter was an egg donor and later died of colon cancer, has written: “Right now, egg donors are treated like vendors, not as patients. Patients need to be followed up.”9 As many egg providers will attest, after the first few days of being discharged with no immediate consequences, they are never contacted again.

As current and former women who have provided their eggs increasingly pool their experiences and provide a growing body of anecdotal evidence pointing to significant harms, especially in cases where women provide eggs on multiple occasions, we need to establish a more rigorous system of evaluating the risks. Studies sponsored by independent researchers, the government and other responsible entities can provide the evidence that is currently lacking and finally make truly informed consent possible. Collecting more thorough safety data will allow young women to better assess the pros and cons of exchanging their eggs for cash.

An earlier version of this article first appeared on WBUR’s CommonHealth, http://www.wbur.org/commonhealth/2016/03/28/patient-protection-egg-donors.

Article written by: Judy Norsigian and Dr. Timothy R.B. Johnson

Timothy R.B. Johnson, M.D., is chair of obstetrics and gynecology, University of Michigan, Ann Arbor; Judy Norsigian is co-founder and past executive director, Our Bodies Ourselves.


References:

1. Centers for Disease Control and Prevention (CDC), Assisted Reproductive Technology, Atlanta: CDC, no date. Available online at: http://www.cdc.gov/art/index.html.

2. Kawwass JF,  Monsour M,  Crawford S, et al., for the National ART Surveillance System (NASS) Group, “Trends and Outcomes for Donor Oocyte Cycles in the United States, 2000-2010,” JAMA 2013; 310(22):2426-2434. doi:10.1001/jama.2013.280924.

3. Edwards B, “The High Costs of Giving up Your Eggs,” NYU Livewire, no date. Available online at: http://journalism.nyu.edu/publishing/archives/livewire/archived/high_cost_eggs.

4. Merritt T, Phillips R, Goldstein M, et al., Position Statement — Ethical Use of Assisted Reproductive Technologies: A Call for Greater Transparency, Better Counseling of Prospective Parents, and Single Embryo Transfer to Improve Outcomes for Mothers and Babies, National Perinatal Association, 2014. Available online at: http://www.nationalperinatal.org/Resources/NT-MAR14-NPA.pdf.

5. National Cancer Institiute (NCI), Cancer Drugs: Leuprolide Acetate, Bethesda MD: NCI, September 17, 2014. Available online at: http://www.cancer.gov/about-cancer/treatment/drugs/leuprolideacetate

6. Redwine D, “Laparoscopic Excision of Endometriosis,” available online at: https://www.facebook.com/permalink.php?story_fbid=283184988378691&id=195664767130714

7. Myers ER, “Outcomes of Donor Oocyte Cycles in Assisted Reproduction,” JAMA 2013; 310(22):2403-2404. doi:10.1001/jama.2013.280925.

8. Spar D, “The Egg Trade — Making Sense of the Market for Human Oocytes,” N Engl J Med 2007; 356:1289-1291. DOI: 10.1056/NEJMp078012.

9. Schneider J, “Fatal colon cancer in a young egg donor: a physician mother’s call for follow up and research on the long-term risks of ovarian stimulation,” Fertility and Sterility 2008; 90(5): 2016e1-e5. doi: 10.1016/j.fertnstert.2007.12.074.