Reproductive medicine guidelines called effective

A study notes a decline in multiple births suggests that further regulation of assisted reproduction is not needed.

By Andis Robeznieks, amednews staff. May 10, 2004.

On the heels of a report from the President's Council on Bioethics calling for more self-regulation in the medical field of assisted reproduction, a study published in the New England Journal of Medicinesuggested not only is the field already engaging in self-regulation, but it's working.

Specifically, the study noted that since the American Society for Reproductive Medicine issued guidelines in 1998 aimed at lowering the number of multiple births created by assisted reproduction embryo-transfer techniques, the percentage of pregnancies with three or more fetuses has "significantly decreased."

Embryo limits
One at a time
Links
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"It looked like it [the decrease] was at least associated with recent changes in the guidelines," said Mark D. Hornstein, MD, one of the study's authors and director of the division of reproductive medicine at Brigham and Women's Hospital, Boston.

Dr. Hornstein and the study's lead author, Tarun Jain, MD, a reproductive endocrinologist at Brigham and Women's Hospital, said the study was not a reply to the bioethics council's March report, "Reproduction and Responsibility: The Regulation of New Biotechnologies."

"The timing turned out to be serendipitous but advantageous to the body of work getting noticed," Dr. Jain said.

Costs and health risks associated with multiple births prompted the ASRM to develop guidelines on the number of embryos transferred. Using data from the Centers for Disease Control and Prevention, researchers found that the number of embryos transferred has decreased since then, with the steepest decline between 1998 and 1999 (11.1%). Simultaneously, the number of multiple births also declined, with a 20.8% decrease reported between 1998 and 1999.

The study noted that Brazil, Denmark, Germany, Hungary, Saudi Arabia, Singapore, Sweden, Switzerland and the United Kingdom have strict laws limiting the number of embryos that can be used per pregnancy cycle. Dr. Hornstein said early drafts of the Bioethics Council report suggested legislation may be necessary in the United States, but this was toned down in the final version.

ASRM spokesman Sean Tipton noted that the success of the guidelines is something that should be recognized by doctors in all fields.

"It's another piece of evidence that it's physicians who ought to be making medical decisions, not insurance companies, not legislators -- not even bioethicists," Tipton said.

ADDITIONAL INFORMATION:

Embryo limits

Recognizing that multiple gestation leads to increased health risks for the mother and fetuses, the American Society for Reproductive Medicine has guidelines for embryo transfer:

	Factors	Prognosis	Quality embryos
Younger than 35	Embryos of sufficient quality and quantity in storage	Most favorable	No more than 2
Younger than 35	No embryos in storage	Above average	No more than 3
35-40	None	Average	No more than 4
Older than 40	Multiple failed cycles	Below average	No more than 5

Source: "Guidelines on Number of Embryos Transferred," revised November 1999

One at a time

Live births from assisted pregnancy continue to increase, but multiple births are going down.

	1997	1998	1999	2000	2001
Percentage of live births
Younger than 35	30.7%	32.0%	32.2%	32.8%	35.2%
35-37	25.5%	26.0%	26.2%	26.7%	28.4%
38-40	17.1%	17.9%	18.5%	18.5%	19.6%
Older than 40	7.6%	8.2%	8.2%	7.7%	8.4%

Percentage of triplets or more
Younger than 35	13.7%	12.5%	9.4%	8.5%	8.1%
35-37	11.3%	10.3%	8.6%	8.1%	7.8%
38-40	6.8%	6.8%	6.6%	6.0%	6.2%
Older than 40	2.8%	4.1%	2.5%	2.9%	2.5%

Source: New England Journal of Medicine, April 15

Weblink

"Trends in Embryo-Transfer Practice and in Outcomes of the Use of Assisted Reproductive Technology in the United States," New England Journal of Medicine, April 15 (content.nejm.org/cgi/content/full/350/16/1639)

"Assisted Reproductive Technology in the United States," New England Journal of Medicine, April 15 (content.nejm.org/cgi/content/full/350/16/1603)

"IVF Outcomes Improving in United States," Brigham and Women's Hospital press release on the study published in the April 15 New England Journal of Medicine (www.brighamandwomens.org/publicaffairs/newsreleases/ivf_outcomes_04_14_04.asp)

"Reproduction and Responsibility: The Regulation of New Biotechnologies," President's Council on Bioethics report, March (bioethics.gov/reports/reproductionandresponsibility)

"Guidelines on Number of Embryos Transferred," American Society for Reproductive Medicine practice committee report, amended November 1999, in pdf (www.asrm.org/Media/Practice/NoEmbryosTransferred.pdf)