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Fertility doctors tighten guidelines in wake of "octomom" controversy

[Quotes CGS's Marcy Darnovsky]

by Kevin B. O'ReillyAmerican Medical News
November 9th, 2009

After heated controversy last winter over the birth of octuplets conceived through in vitro fertilization, the American Society for Reproductive Medicine in October announced tightened practice guidelines and a willingness to work with policymakers to put teeth into its recommendations.

ASRM did not change its guidance on the number of embryos to transfer based on different patient prognoses. But it asked that doctors who exceed the recommendation transfer only one additional embryo, note the decision in the medical record and caution patients about the risks of multifetal pregnancies. The society said it is rare that patient circumstances will warrant exceeding its guidelines.

ASRM also said the number of embryos transferred should not differ based on whether they are fresh or cryopreserved, citing evidence showing that success rates are about the same.

In the octuplets case, patient Nadya Suleman said her physician transferred six frozen embryos, and two of them split.

"It is clear that these guidelines have a terrific impact on clinical practice," said R. Dale McClure, MD, ASRM's immediate past president. "Over the years, we have seen a reduction in the number of high-order multiple births while maintaining strong success rates. This latest revision is our most recent effort to help our members provide their patients with the best, safest care possible."

In September, ASRM revoked the membership of Suleman's fertility doctor, Michael M. Kamrava, MD. Last February, the Medical Board of California said it was investigating the Suleman case. At this article's deadline, the board had not taken any action against Dr. Kamrava. He did not respond to inquiries from American Medical News.

The society took its action against Dr. Kamrava after a fact-finding and appeals process, said ASRM spokesman Sean Tipton.

"There was a persistent pattern of failing to uphold the standards we expect from our members," Tipton said. "We don't have the capacity to determine who the patient's going to see or [stop] someone from practicing medicine, but we would hope that patients would take this action as seriously as we did."

Revoking membership is not a common action for the society, Tipton said, declining to disclose how many times it has been done. Since the society first adopted embryo-transfer guidelines in 1997, IVF-conceived births of triplets or higher-order multiples has declined by 60%.

The American Medical Association does not have policy regarding how many embryos to transfer in IVF, but does say doctors should inform patients about "all aspects of [assisted reproductive technology] applicable to their particular clinical profile."

Regulation? Maybe

The "octomom" controversy's high profile has drawn added scrutiny of assisted reproductive technology practices.

At least three states this year considered legislation to regulate IVF clinics, but none was passed. ASRM Executive Director Robert W. Rebar, MD, said in September that "the time has come for policymakers to sit down with the leading experts in the field to explore ways we can codify our standards to give them additional regulatory teeth."

Tipton said the society is convening a meeting Dec. 14 in Washington, D.C., to explore regulatory and legislative options.

While fertility specialists are nearly unanimous in their condemnation of the medical decisions that led to Suleman's IVF-conceived octuplets, some were skeptical about regulation.

"The apparent open invitation by any professional medical society for heavy-handed government intrusion in the physician-patient relationship is, frankly, shocking," said Samuel H. Wood, MD, PhD, a La Jolla, Calif., reproductive endocrinologist. "The ASRM has taken patients and physicians to the top of the proverbial slippery slope and is apparently encouraging them to jump off. And this slope is particularly steep and slippery, because it involves the government mandating the specific medical treatment for what are commonly very complicated medical conditions. Codification of these standards would be a tragic error that would severely restrict the ability of physicians to provide appropriate, individualized medical care to their patients."

ASRM's openness to regulation "is ridiculous," said James A. Grifo, MD, PhD, program director of the New York University Fertility Center. "It may be a good effort, but what are they trying to accomplish? Everyone has the goal of not having multiples, but the more you have a regulatory agency interfere with your ability to practice medicine, the more unintended consequences will occur."

Others said government action is long overdue.

"The whole fertility clinic dynamic is that they are competing with each other, advertising success rates, and that dynamic comes into play in some of the practices that should go away," said Marcy Darnovsky, PhD, associate executive director of the Center for Genetics and Society, an advocacy group in California. "There are a lot of fertility doctors who have lots of integrity and are completely responsible, but it's a situation where, because of the lack of public policy, it creates -- and encourages -- bad apples."

Limiting embryo transfers

The American Society for Reproductive Medicine tightened its guidelines in October, saying the number of embryos transferred should not differ based on whether they are fresh or frozen. Also, doctors should counsel patients on the risks of multifetal pregnancies. If doctors choose to transfer more embryos than recommended, they should only transfer one more.

Cleavage-stage embryos (2 or 3 days after fertilization) Blastocysts (5 or 6 days after fertilization)
Patient age Favorable prognosis All others Favorable prognosis All others
Younger than 35 1-2 2 1 2
35-37 2 3 2 2
38-40 3 4 2 3
41-42 5 5 3 3

Note: Indications of favorable diagnosis include it being the first cycle of IVF, good embryo quality, excess embryos available for cryopreservation or previous successful IVF cycle.

Source: American Society for Reproductive Medicine Practice Committee guidelines, Fertility and Sterility, November (www.fertstert.org/article/S0015-0282%2809%2903625-5/)

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