A New Measure in Fertility Testing

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The Wall Street Journal

A New Measure in Fertility Testing
Doctors Say Hormone Gauge Gives an Accurate Egg Count; Still Awaiting FDA Clearance
By HEATHER WON TESORIERO
April 22, 2008; Page D1

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When it comes to a woman's biological clock, it's all about the eggs: How many does she have, and are they healthy enough for conception? A hormone test gaining wider use in the U.S. may offer women a more precise way to assess their ovarian inventory, compared with the tests in common use for years. This test measures a chemical produced in the body called anti-mullerian hormone, or AMH, which has been shown to provide an accurate snapshot of a woman's egg count. Over the past few years, the test, which reads AMH levels from a blood sample, has been routinely available in Europe, where much of the research on AMH as an ovarian-reserve marker has been done.

But the lack of uniform measurement standards has slowed its adoption in the U.S., where such tests come under Food and Drug Administration oversight. AMH-detection systems haven't yet satisfied FDA criteria for clinical use. Even though it awaits clearance, there has been no move to restrict use of the test in doctors' offices. Moreover, doctors aren't quite ready to completely abandon older measures to test fertility, because they think a robust battery of data can be useful. There is also some debate about whether AMH levels correlate to egg quality. Other factors, too, such as the vitality and mechanics of reproductive organs, affect the ability to get pregnant.

Still, as recent scientific literature has bolstered the predictive credentials of AMH detection, and measures have become more consistent, a growing number of physicians are using the test at their discretion. The cost of the test runs from $100 to $400, which is covered by some, but not all, health insurers... Until it receives FDA clearance, the $350 test is available only through participating physicians in 24 cities. Women in those areas can also order the test online and have a participating physician draw her blood. The test is sent to Repromedix for processing. Benjamin Leader, the company's chief medical officer, says AMH "plays a significant role" in the test.

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The first studies that looked at AMH as a marker for ovarian reserve appeared in 2002 and showed that the hormone, which is produced by egg follicles, declines with age. A paper published last year in the journal Fertility and Sterility looked at data from a series of AMH studies and concluded that it is the earliest marker of ovarian reserve and has the least variability during and between a woman's menstrual cycles. An older, commonly used egg-supply marker known as follicle-stimulating hormone, or FSH, also measured through a blood test, can be taken only on days two, three or four of a menstrual cycle, may be affected by birth-control pills, and has greater variability. By contrast, "AMH tends to be very consistent," which means a reading can be taken at any time, says Arlene Morales, chief medical officer of Fertility Specialists Medical Group in San Diego. Her clinic started offering AMH testing a year ago, and she says it now uses it in a majority of patients.

"AMH is an early marker of ovarian aging, whereas FSH becomes elevated at a later reproductive age," says David Seifer, co-author of the Fertility and Sterility paper and a professor of obstetrics, gynecology and reproductive sciences at Mount Sinai School of Medicine in New York. Dr. Seifer practices at Genesis Fertility in Brooklyn, N.Y., which recently started offering AMH testing to patients. "Once a woman's FSH levels are elevated, it's often a signal that she has diminished ovarian reserve and therefore is at a much greater challenge of conceiving." In other words, by the time her FSH level rises, it may be too late.

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