Most fertility clinics break the rules

[February 21, 2009]  NEW YORK (AP) -- The California fertility doctor who implanted the octuplet mom with lots of embryos was no lone wolf: Fewer than 20 percent of U.S. clinics follow professional guidelines on how many embryos should be used for younger women. "Clearly, most programs are not adhering to the guidelines," said Dr. Bradley Van Voorhis, director of the fertility clinic at the University of Iowa.

The furor over Nadya Suleman and her octuplets has brought scrutiny to U.S. fertility clinics and how well they observe the guidelines, which are purely voluntary. The controversy had led to talk of passing laws to regulate clinics, something that has already been done in Western Europe.

"There are enough clinics that quite openly flout professional guidelines that we really do need to start thinking about public policy in this area," said Marcy Darnovsky of the Oakland, Calif.-based Center for Genetics and Society, a public interest group. "I think it's way overdue."

The 20 percent figure is contained in reports filed by clinics with the Centers for Disease Control and Prevention.

Fertility doctors say there are many reasons clinics skirt the guidelines: pressure from patients who want to use more embryos to improve their chances of getting pregnant; financial concerns from those who are paying for their treatment out of their own pockets; and the competition among clinics to post good success rates.

And the only penalty for violating the guidelines is expulsion from some of the industry's professional organizations, though that can affect whether insurance companies will cover a clinic's treatments.

"You have patients who are desperate and you have doctors who are driven by success rates. It's not a good combination," said Pamela Madsen, founder and former head of the American Fertility Association.

When the guidelines were issued in 1996 by the American Society of Reproductive Medicine, the intent was to cut down the number of multiple births, particularly triplets and higher, that can result when many embryos are implanted and more than one takes. Big multiple births can lead to disastrous, life-threatening complications, lifelong disabilities such as cerebral palsy, and crushing medical costs.

The guidelines suggest how many embryos doctors should use, with the number varying by age and other factors. They also allow for some flexibility for more if previous attempts have failed or the embryo quality is poor.

"These decisions are complex and need to be individualized, which is why we strongly believe that guidelines are better than hard rules," said Dr. David Adamson, a former president of the reproductive medicine society.

The group credits the guidelines with reducing triplets and higher multiple pregnancies from 7 percent of attempts to 2 percent in 2006. Nearly two-thirds of the procedures involved four or more embryos in 1996; that has fallen to 16 percent.

But for women under 35, government records show that just 83 of 426 clinics followed the guidance calling for one and no more than two embryos. The average for fresh embryos (as opposed to frozen) implanted in women in that age group ranged from a 1.4 to 4.8. The vast majority of the clinics averaged between two and three embryos.

Dr. Mousa Shamonki, director of the IVF program at the University of California, Los Angeles, said his patients frequently ask for more embryos to boost their chances of getting pregnant. He tells patients that it's not OK to end up with triplets or even twins.

"The only thing that happens when you add additional embryos is you're increasing the multiple pregnancy rate," he said. "You're rarely increasing the overall pregnancy rate significantly."

The UCLA program had one of the highest transfer rates in 2006 for younger women. That rate - 3.5 embryos per cycle - matched that of the West Coast IVF Clinic in Beverly Hills, Calif., where Suleman was treated. Shamonki said changes he implemented after he took over drove down UCLA's rate to 2.1 embryos the next year.

Fertility specialists have attacked Suleman's doctor, Michael Kamrava, for using so many embryos. Suleman, 33, has said she had six embryos implanted; two presumably split. She said she refused selective abortion to reduce the number, which is a common option in such cases. Kamrava has declined requests for interviews.

The reproductive medicine society and the Medical Board of California are looking into the case.

Europe has brought down transfer rates and multiple births through laws and voluntary agreements. England and Sweden have laws barring more than two embryo transfers for younger women.

In Sweden, "we have a slogan: One at a time," said Dr. Karl Nygren, former head of an IVF monitoring committee for the European Society of Human Reproduction and Embryology.

Seventy percent of in vitro fertilization procedures in Sweden involved only a single embryo in 2005, according to Nygren. For Europe, the average was 20 percent. By contrast, only 11 percent in the U.S. involved one embryo in 2006.

A key difference, though, is that health programs in Europe cover the cost, so that if one attempt fails, women can try again without having to worry about the expense.

In the U.S., most patients have to foot the bill for IVF, which costs about $12,400 per attempt. Only 14 states make insurers cover some infertility treatments.

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On the Net:

CDC fertility clinic reports: http://www.cdc.gov/ART/

[Associated Press; By STEPHANIE NANO]

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