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Last updated on February 10, 2012 at 7:50 EST

Majority Of Fertility Clinics Fail To Meet Guidelines

February 21, 2009
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Anger over Nadya Suleman and her octuplets has brought scrutiny on U.S. fertility clinics, with many questioning whether they adhere to voluntary guidelines on how many embryos should be used for younger women.  The controversy had even led to talks of passing new laws to regulate these clinics, such as those already in place in Western Europe.

“Clearly, most programs are not adhering to the guidelines,” Dr. Bradley Van Voorhis, director of the fertility clinic at the University of Iowa, told the AP.  

Indeed, fewer than 20 percent of U.S. clinics follow professional guidelines regarding the number of embryos that should be implanted in younger women, according to reports filed by clinics with the Centers for Disease Control and Prevention (CDC).

“There are enough clinics that quite openly flout professional guidelines that we really do need to start thinking about public policy in this area,” Marcy Darnovsky of the public interest group Center for Genetics and Society told the Associated Press.

“I think it’s way overdue.”

Fertility doctors say there are many reasons clinics abandon the guidelines, such as pressure from patients seeking to use more embryos to improve their chances of getting pregnant.  Financial concerns often play a role, since many pay for their treatment out of their own pockets. And competition among clinics to post good success rates can also be a factor.

Currently, the only penalty for violating the guidelines is expulsion from some of the industry’s professional organizations, something that can affect whether insurance companies cover treatments at the clinic.

“You have patients who are desperate and you have doctors who are driven by success rates. It’s not a good combination,” Pamela Madsen, founder and former head of the American Fertility Association, told the AP

The guidelines, issued by the American Society of Reproductive Medicine in 1996, were put in place with the goal of reducing the number of multiple births, especially triplets and higher, that can result when a high number of embryos are implanted and more than one takes.  Large multiple births can lead to devastating, life-threatening complications, lifelong disabilities such as cerebral palsy, and enormous medical costs.

The guidelines include recommendations on how many embryos doctors should use, depending on a woman’s age and other factors. They also include provisions with more flexibility for additional embryos if previous attempts have failed or there was poor embryo quality.

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

The group said the guidelines have helped reduced triplets and higher multiple pregnancies from 7 percent of attempts to just 2 percent in 2006.  In 1996, nearly 70 percent of the procedures involved four or more embryos, a number that has since fallen to 16 percent.

However, for women under 35, government data shows that just 83 of 426 clinics adhered to the guidance calling for one and no more than two embryos. The average for fresh, as opposed to frozen, embryos implanted in women under 35 ranged from a 1.4 to 4.8. And a high percentage of the clinics averaged between two and three embryos.

Dr. Mousa Shamonki, director of the IVF program at the University of California, Los Angeles (UCLA), said his patients often request more embryos to increase their chances of getting pregnant.  However, he advises patients that triplets or even twins can be problematic.

“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.”

In 2006, the UCLA program had one of the highest transfer rates, at 3.5 embryos per cycle, for younger women. That rate was matched by the West Coast IVF Clinic in Beverly Hills, Calif., where Suleman, 33, was treated.  

Shamonki said changes he implemented after he took charge of the clinic decreased UCLA’s rate to 2.1 embryos the following year.

Fertility experts have criticized Suleman’s doctor, Michael Kamrava, for using so many embryos. Suleman has said she had six embryos implanted, two of which presumably split. She said she refused selective abortion, a common option in these cases, to reduce the number. The reproductive medicine society and the Medical Board of California are investigating Suleman’s case.

Europe has reduced transfer rates and multiple births through a combination of laws and voluntary agreements. Sweden and Britain have laws prohibiting more than two embryo transfers for younger women.

“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, referring to Sweden.

Seventy percent of Sweden’s in vitro fertilization procedures involved a single embryo in 2005, Nygren said. For Europe, the average was 20 percent, compared with just 11 percent in the U.S.  A critical difference, however, is that Europe’s health programs cover the cost of the treatments, so that if one attempt fails, women can try again without having to incur the added expense.

In the U.S., most patients have pay for the IVF treatments, which cost about $12,400 per attempt, out of their own pockets.  Just 14 states require insurers cover some portion of infertility treatments.

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On The Net:

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