|HAYLIE MARCHANT, 25, of Chicago, looks away as she has her blood drawn by Molly Murphy at Fertility Centers of Illinois. Marchant is there for a blood test to find out her 'ovarian reserve' to determine how many eggs she has. (NANCY STONE, MCT / April 23, 2008)|
A new medical test for women who want to check their biological clocks is debuting in Chicago amid concerns about its usefulness and enormous interest in the consequences of delayed childbearing.
Called Plan Ahead, it's the first fertility test that purports to measure a woman's "ovarian reserve" - how many good eggs she has available for conception.
In a controversial move, the $350 test will be marketed to women who are contemplating when to have children and who want to recognize any potential biological limitations.
Dr. Benjamin Leader, chief medical officer for the company marketing the test, Repromedix, compares the test to checking the gas gauge on a car to see how much is left in the tank.
But some fertility experts worry that the sales pitch will capitalize on women's anxieties and note that the test's reliability has not been clearly established.
"Given the state of the science, I think it's premature to offer this test," said Dr. Ralph Kazer, chief of reproductive endocrinology and infertility at Northwestern University's Feinberg School of Medicine.
"Will this tell a woman will she or will she not become pregnant? No it will not, and I'm not sure what the value is," said Dr. Zev Rosenwaks, director of the Center for Reproductive Medicine and Infertility at New York Weill Cornell (Medical) Center.
But experts also acknowledge that many women, especially those in their late 20s or 30s, are hungry for a better sense of their childbearing potential.
"I know lots and lots of professional women who would like to have this information," said Richard Rawlins, director of the Centers for Advanced Reproductive Care at Rush University Medical Center.
Plan Ahead could be especially valuable for women in their mid- to late 30s who have had trouble getting pregnant and want to evaluate whether they're good candidates for in vitro fertilization, Rawlins said.
Officials at Fertility Centers of Illinois plan to begin offering the test in the next several weeks, joining centers in 10 other states that are embracing the technology.
"We think this will help women concerned about their fertility and trying to decide if they have time to start a family," said Dr. Kevin Lederer, president of Fertility Centers of Illinois, which operates 10 clinics around Chicago. Insurance may or may not cover the expense, depending on the policy.
The test measures three hormones closely associated with the number of eggs in women's ovaries: follicle stimulating hormone (FSH), which stimulates egg development; anti-mullerian hormone (AMH), produced by cells surrounding immature eggs; and Inhibin B, a protein produced by egg follicles.
The hormone tests aren't new; the innovation is a mathematical formula that analyzes results from the tests and other factors, such as age and estrogen levels, to derive a score for a woman's ovarian reserve.
Several experts expressed reservations about the AMH test, which U.S. fertility centers are just beginning to use. The Food and Drug Administration has not approved it for commercial distribution.
"We don't use it, and we won't use it clinically until it's FDA approved," said Dr. Mark Hornstein, director of the reproductive endocrinology and infertility at Brigham and Women's Hospital in Boston, an affiliate of Harvard Medical School. Nor does his group think testing women for Inhibin B is particularly useful.
Dr. Alan Penzias of Boston IVF, one of the nation's leading fertility clinics, concluded otherwise. "The combination of these three tests is more powerful predictively than any individual test on its own, and we think the results are helpful," he said.
Leader said officials with Repromedix will meet with the FDA in the next 60 days to discuss the product and whether FDA clearance is necessary under new guidelines issued by the agency.
Women are born with a lifetime's supply of eggs, which they begin to shed once menstruation begins. A woman's prime childbearing years are her 20s and early 30s; after age 35, the chance she'll become pregnant in a given month declines dramatically.
An important factor in conception - but not the only one - is how many high-quality eggs are available to be fertilized. Some women have more than adequate supplies through their 30s and into their 40s; others don't. As women age, the viability of their eggs diminishes, which impairs fertility.
Repromedix is careful to state clearly what the Plan Ahead test can't do. Most importantly, the test can't tell whether or not a woman is fertile; all it can report is her current risk of having a low supply of high-quality eggs. Nor can it predict how fast her supply of eggs is likely to shrink in years ahead.
Women with low ovarian reserve scores will want to consult with their doctors about options, Leader said. To ensure physicians are involved, the firm requires that doctors order Plan Ahead and sends results to their offices.
Repromedix has yet to publish results in a peer-reviewed journal from a study of 200 women that the company said correlated women's ovarian reserve scores with the number of eggs produced when they undergo ovarian stimulation.
That troubles Kazer of Northwestern, who thinks the clinical data should be thoroughly vetted before Plan Ahead is marketed to women.
"What if some women take the test, get a good score and choose to delay having a child" only to learn later that another issue is interfering with their fertility, such as abnormalities in the reproductive tract, he asked. "We don't know how much false reassurance this test is going to generate."
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