Egg donation poses risks for fertility clinics
Study questions risk info given to donors
They appear in almost every college newspaper and urban entertainment weekly. Enticing advertisements promise thousands of dollars to young women willing to donate eggs to help infertile couples conceive. For many, this seems like a win-win proposition — you get needed money for school while helping others have a child they desperately want.
But oocyte donation, as the process is more formally known, is not exactly a risk-free procedure. Reported complications include induction of premenstrual syndrome-like symptoms, ovarian hyperstimulation syndrome (OHSS), and a possible increased risk of ovarian cancer due to the strong fertility drugs administered.
With more and more couples seeking donor eggs and a shortage of women willing to part with theirs, some ethicists worry that assisted fertility programs have too much incentive to play down the risks and offer women ever-increasing sums of money.
"Egg donation programs need to recruit oocyte donors to maintain a financially viable business," says Andrea D. Gurmankin, MA, a graduate student in psychology at the University of Pennsylvania’s Center for Bioethics in Philadelphia. "I think that offering young women thousands of dollars combined with the incentives that these programs have to minimize the risk has the potential to lead to a very bad situation."
Gurmankin published a pilot study in the fall 2001 issue of the American Journal of Bioethics that evaluated the risk information provided by several in vitro fertilization (IVF) programs during preliminary phone interviews.
Posing as a potential donor, Gurmankin called 19 different programs nationwide and asked for information about the egg-retrieval process and any risks involved. Here are some of her findings:
- 26% of the programs called did not volunteer information about the procedure or any risks involved.
- 21% of the programs would not answer questions about the procedure or about the risks of the procedure over the phone, instead referring the caller to information that would be sent by mail.
When the information sent by mail was included in the overall consideration of the risk information provided:
- 21% of the programs volunteered information about the risk of infection.
- 32% volunteered information about the risk of vaginal bleeding.
- 32% volunteered information about PMS symptoms.
- 32% volunteered information about the risk of OHSS.
- 5% volunteered information about a possible risk of ovarian cancer.
Only 5% of the programs contacted volunteered any information over the phone about possible risks, while 32% of the programs mentioned the amount of financial compensation given.1
The results do not necessarily indicate that the programs don’t give complete information prior to accepting women as egg donors, Gurmankin admits. But it does raise questions about whether the donors truly make an objective decision.
"I am not suggesting that they don’t get complete and voluntary informed consent before asking the woman to donate," she says. "But I am still worried about the fact that they are not giving complete information at this preliminary phone call point."
Several psychological studies have shown that incomplete information given at a project’s outset can bias information that is provided at a later date, she explains.
"There is the concept in psychology called lowballing,’" Gurmankin continues. "The idea is that if you can induce a person to make some sort of real commitment — like coming in for a medical screening — toward a desired action, like egg donation, should you later make that action less desirable by fully informing that person of the risks. They are still less likely to back out than they would have been had they known the full information at the outset."
There is a kind of behavioral commitment at the outset that makes it difficult for participants in an activity to "back out" once other people expect them to continue, she says.
"For a young woman, it is conceivable that it is very difficult to say no’ once you have made some commitment," she adds. "And just in general, people tend to be unrealistically optimistic about the risks that they may face. I can only imagine how this is enhanced in the face of thousands of dollars in compensation."
Study does not evaluate consent process
Although Gurmankin’s project raises some interesting points, the study results don’t reliably reflect the risk information provided by these programs, says Mark V. Sauer, MD, professor of medicine and director of reproductive endocrinology at Columbia University in New York City. Sauer wrote an accompanying editorial that was published in the same issue as Gurmankin’s piece.
"The article had major flaws in study design that greatly limit, if not negate, its importance," he tells Medical Ethics Advisor. "That is not to say that problems do not exist. They do, but mainly in the area of informed consent. I do not believe this paper adequately addresses any of these issues and therefore, more and better studies need to be performed."
There is approximately a 1% complication rate in women undergoing these procedures, he notes. These risks are well defined and should be disclosed.
But, Sauer says, the risk issues can only be adequately explained and discussed by trained personnel. Personnel ordinarily available to answer the phone would not be qualified to give out such information.
"Our program, as most good ones, provides a fair amount of information, both written and verbal, to prospective donors prior to enrolling them in the program," he says. "This is a dynamic process, typically involving physicians, social workers, or a mental health professional, and nurses. The process requires several visits and time as well, which gives the donor adequate time to back out if she has concerns."
The preliminary phone conversation has about the same place in the informed consent process as the recruiting ads placed in newspapers, says Rebecca Dresser, JD, the Daniel Noyes Kirby professor of law and professor of ethics in medicine at Washington University in St. Louis. Dresser also served on the working group that wrote the Birmingham, AL-based American Society for Reproductive Medicine (ASRM) guidelines on offering financial compensation to egg donors.
"If you’re calling up a program, you might get the receptionist," she says. "I don’t think she would need to discuss specific medical information. But it seems to me that the receptionist, like the advertisement, should at least say that there are some risks to the procedure. What we said in our [ASRM] statement is that if the advertisement discusses benefits or positive aspects of donation, and usually that is the financial compensation, it should also note the presence of risks, making some general statement to highlight that."
Dresser agrees with Gurmankin’s concern that prospective donors’ early perceptions of the procedure will color their decision-making process later.
"The way the ads and the initial phone conversation affects the donor’s initial perception can be an important influence," she agrees. "The initial impression needs to be balanced."
Are they patients or research subjects?
Part of the problem with ensuring informed consent for oocyte donors is that they sort of fall into a gray area between clinical medicine and medical research.
Their situation is most like human subjects recruited for research studies because they are being asked to undergo a procedure that poses some risks, but for which they can expect to receive no medical benefit, say both Gurmankin and Dresser.
"They are putting themselves at some risk. Yet, as a society, I think we would say it is a reasonable risk," Dresser explains. "But it is a significant risk and it is not really for their benefit."
Using the research subject criteria, fertility programs are obligated to make sure the risks to the donor are not unreasonable, that the donor understands the risks, and that the amount of compensation does not coerce them into consenting.
But, unlike many human research studies that receive federal funding or are conducted at an institution that does, fertility programs are not required to have an IRB approve its informed consent procedures or recruitment protocols, says Gurmankin. "There are no measures in place to protect egg donors, and I think that they are needed."
Though egg donors are in a similar situation to human research subjects, they are not, in fact, serving in a research protocol, notes Judith F. Daar, a professor of law at Whittier School of Law in Costa Mesa, CA.
They are, however, undergoing a medical procedure under the supervision of a doctor that should qualify them as a patient of that physician, she says. What is unclear to her is whether the physicians involved perceive the donors this way.
"I am not even sure that the egg donors are looked at as patients," she says. "I think the argument can be made that if they are not looked at as patients and merely as an instrumentality to achieve a goal of pregnancy for another woman, then they would not be seen as eligible for informed consent. That may be taking it a bit far. I don’t think donors are actually treated this way. But the potential is there."
In many programs, one physician supervises both the oocyte retrieval from the donor and the IVF procedure for the woman or the couple seeking treatment, she says.
This raises conflict-of-interest issues that go even beyond the informed consent process.
"If there are complications, such as hyperstimulation of the donor’s ovaries, is the physician going to feel an obligation to stop the cycle to protect the health of the donor or continue to obtain the best outcome for the woman who wants to become pregnant?" she asks.
Daar participated in a working group in California several years ago comprised of attorneys who practiced in the area of assisted reproduction. A number of attorneys reported concerns about clients who were oocyte donors, she says.
"They felt that there were not only problems with informed consent, but some felt that there was a neglect of the health of the donors, some of whom were being hyperstimulated and suffering a number of different side effects from the drugs," she states. "They felt these issues were being given little attention by the assisted reproductive technology community as well as the bioethics community."
Many say that such ethical concerns, on top of the dilemmas already raised by the rapidly changing assisted reproduction industry, must inevitably result in some sort of government oversight.
In 2000, the California legislature passed a bill requiring fertility programs to provide oocyte donors with a "standardized" written form detailing the potential risks of oocyte donation. The governor refused to sign the bill into law because the state health department was developing a standardized form to be used by all programs throughout the state, says Daar. The form still is in development.
The ASRM has published guidelines on informed consent for oocyte donors and on appropriate financial compensation for donors, but compliance with these standards is completely voluntary and is not monitored. (See "Elements for obtaining ART informed consent," in this issue.)
The only way to ensure that fertility programs adhere to certain ethical standards is by state regulation, which is virtually nonexistent across the country now.
"There is no formal review process now and maybe there should be," says Dresser. "There is a lot of conversation now about how this area is unregulated. One way to do it would be to have some sort of institutional review requirement and ensure that the programs have to be approved regularly."
Reference
1. Gurmankin A. Risk information provided to prospective oocyte donors in a preliminary phone call. Am J Bioethics 2001; 1(4):3-13.
Sources
- Judith F. Daar, Whittier School of Law, 3333 Harbor Blvd., Costa Mesa, CA 92626.
- Rebecca Dresser, Washington University, Law School-Box 1120, One Brookings Drive, St. Louis, MO 63130.
- Andrea Gurmankin, Center for Bioethics, University of Pennsylvania, Suite 320, 3401 Market St., Philadelphia, PA 19104-3308.
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