Ethics for extra embryos: Doctors face a dilemma

News reports concerning the nation's inventory of 400,000 cryopreserved embryos can conjure up images of overflowing fertility clinic freezers surrounded by clinicians scratching their heads over what to do with all of the embryos that have been abandoned by the couples who created them.

The number, much higher than previous estimates that ranged from 30,000 to 200,000, comes from a 2003 embryo census conducted by the Society for Assisted Reproductive Technology. But reproductive specialists note that the vast majority of stored embryos -- almost 350,000 -- are still earmarked for future fertility treatments. And of those, 35% likely would not survive the thawing process.

Arlene J. Morales, MD, medical director of the Sharp Fertility Center in San Diego, thinks the perception that fertility clinics are overstuffed with extra embryos is the result of press sensationalism. "The media seems to highlight couples who don't know what they want to do," she said. "But in my experience, most couples intend to save them for future use."

The American Society for Reproductive Medicine recommends using one to five embryos per treatment, depending on the woman's age and other risk factors.

Better technology and more sensitivity is leading fertility clinics to use and create fewer embryos in the first place, said both Dr. Morales and Jeffrey Keenan, MD, medical director of the Southeastern Fertility Center in Knoxville, Tenn.

"I think the biggest hot topic is single-embryo transfer," Dr. Morales said. "We are certainly working toward decreasing multiple births with the goal of a delivering a single, healthy baby."

When this goal is reached, Dr. Keenan said it would be good news.

"First, I think we should be limiting the number of eggs we are fertilizing," he said. "I don't think we should inseminate 15 or 20 just because a patient is young and has a lot of eggs. We're almost asking for them to be put in an uncomfortable position."

Dr. Keenan's facility has a strict policy on not destroying any leftover embryos when a couple is finished creating a family.

"If they want to work with me, couples need to sign a release saying that if they don't use them, the embryos would be made available for donation to other couples," he said. "If they don't agree, they go elsewhere."

In taking this stand, Dr. Keenan said even poor-quality embryos are used. "Not everyone agrees, but even if an embryo has only a 1% or 2% chance, that's a higher chance than this couple would have if we didn't transfer it," he said.

Dr. Keenan, director of the National Embryo Donation Center, also in Knoxville, thinks that having couples "adopt" and use other couples' embryos is a viable method of getting a handle on the issue of what to do with extra embryos.

The U.S. government has distributed $2 million in grants in the last two years to promote embryo adoption.

Last fall, the National Embryo Donation Center received a $304,000 federal grant to pay for efforts to educated the public about embryo adoption. Just over a year old, NEDC has 200 couples on its waiting list, plus 86 embryos "here or on their way," Dr. Keenan said.

The NEDC has performed eight embryo transfers, and, although it hasn't produced a baby yet, there are two pregnancies.

The Snowflake Embryo Adoption Program in Fullerton, Calif., also has received federal funds to promote embryo adoption. Snowflake Director Lori Maze said its grant of more than $325,000 had been used to produce a series of general videos for clinics and the public about embryo adoption.

The Snowflake program is responsible for 70 babies being born since 1997. At least 15 more are due in 2005, Maze said.

Maze said Snowflake receives its share of "e-mail rantings" that accuse it of encouraging the creation of embryos to populate its program.

"Whether some people like it or not, the embryos are there," she said. "All we're doing is trying to create a solution to a problem that already exists and doesn't look like it's going away in the near future."

New FDA rules

Although one part of the federal government is spending money on promoting embryo adoption, the Food & Drug Administration -- in an effort to provide more protection against the spread of disease -- is set to establish new rules May 25 that could make embryo donation more difficult.

Donors are required to be screened for infectious disease upon donation and again six months later. Dr. Keenan said the new regulations also would require a physical exam along with a complete medical history.

"It's going to stifle the whole embryo-donation movement," he said.

Harvard School of Public Health Professor Andrea Gurmankin, PhD, said creating fewer embryos or donating them to other couples would not do enough to get the number of embryos down to a more manageable level. She is calling for standardization of policies -- not only on embryo storage and disposition -- but for screening practices, informed consent and financial compensation for eggs.

The absence of standardization "can lead to inequities and the potential downward spiral of discrimination," she said. "There's a whole host of issues where there has been a call for debate and standardization."

Dr. Gurmankin's study on embryo disposal practices at 217 IVF clinics published in the journal Politics and the Life Sciences last fall found that what may happen to embryos depends a lot on who is storing them.

For example, of the 175 clinics surveyed that dispose of extra embryos, 166 (95%) said they attempted to contact a couple before disposal, with 110 saying they would not proceed without that contact -- even with prior consent. Also, 136 clinics required permission of both potential parents before disposal.

Dr. Gurmankin's study also turned up some differences among clinics' disposal practices: Four clinics said they required the couple to be present at disposal, 23 gave the option of being present, four gave the embryos to couples to dispose of themselves and seven performed a ceremony that included a prayer.

Dr. Morales said the standardization of policies imposed by outside regulators is unnecessary, as medical groups have been successful in self-regulating fertility treatments.

"Anything that's cutting edge will be politicized to some degree," she said. "I can't imagine a positive outcome from government regulations. [Medical] groups have shown an ability to self-regulate."

ASRM policy states that it is "ethically acceptable" for a clinic to dispose of stored embryos that appear to have been abandoned if there has been no communication with the couple after five years and after "diligent efforts" have been made to contact them. The policy also states that abandoned embryos should not be donated to other couples or for research without prior consent.

Last year, the American College of Obstetricians and Gynecologists' committee on ethics released a report regarding research done on pre-embryos -- cells less than 14 days old. In the report, ACOG called on each IVF program to develop its own policies for transfer, storage, donation, research and disposal of embryos.

The American Medical Association opinion allows for donating extra pre-embryos to other couples or for research but prohibits their sale.

The opinion also calls for deciding in advance what should happen in case of divorce or other "changes in circumstance."

"Predetermination is the best course," said Michael Goldrich, MD, chair of the AMA Council on Ethical and Judicial Affairs. "That predetermination [agreement] should not only address all potential uses for the pre-embryos, it should also address what the policies are for maintaining storage of the pre-embryos."