By Gila Reckess
February 23, 2001
There may be new hope for women who are infertile due to polycystic ovary syndrome (PCOS).
A study published in the February issue of the journal Fertility and Sterility reveals that the drug metformin, when combined with the commonly used fertility drug clomiphene citrate, increases ovulation and the likelihood of pregnancy in patients who are unresponsive to clomiphene alone. The study was a joint effort among researchers from four medical.html centers, including the School of Medicine.
Four to 6 percent of reproductive-age women suffer from PCOS, a condition that prevents regular ovulation. Many of these women ovulate so infrequently that conception is extremely challenging.
Clomiphene citrate is a pill that has been used with relative success --about two-thirds of women who take the pill ovulate, and roughly one-third become pregnant. For those who do not respond, the only viable alternatives today are surgery and injectable fertility drugs, both of which have potentially dangerous side effects.
"We don't want to cause dangerous situations in women who are otherwise very healthy," said Valerie S. Ratts, M.D., assistant professor of obstetrics and gynecology at the medical.html school. "It would be nice to have an alternative way to treat these women safely and effectively."
Research suggests that many of these women also have a type of insulin resistance similar to that seen in type 2 diabetes. The body produces excess insulin to ensure that all cells are sufficiently fueled. Researchers believe that increased levels of insulin may interrupt normal communication between the pituitary gland and the ovary.
Ratts and her colleagues tested the potential of metformin, a drug widely used to treat patients with type 2 diabetes. Women with infertility due to PCOS who were resistant to clomiphene citrate were randomly assigned to either an experimental group or a control group.
Each patient in the experimental group received 500 milligrams of metformin three times a day for seven weeks. She then continued to take metformin and also was given 50 milligrams of clomiphene citrate a day. If she did not ovulate, the dose of clomiphene citrate was increased by 50 milligrams for the next cycle, up to 150 milligrams. Patients continued this pattern for six months or until they became pregnant.
Women in the control group received an inert substance instead of metformin but followed the same dosage and procedure for clomiphene citrate.
Of the 11 participants who received metformin, eight ovulated and six became pregnant. Of the 14 participants who received the inert substance, only three ovulated and one conceived. Therefore, both ovulation and conception were significantly more likely in the experimental group than in the control group.
"By using metformin in PCOS patients, we decreased insulin levels so the ovaries could function more normally and therefore could respond to clomiphene citrate," Ratts said. "It's exciting because metformin is much cheaper than injectable fertility drugs and doesn't present the risk of side effects. And it seems to work."
The research team now hopes to identify factors that predict which patients will respond to the new therapy.
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