CLINICAL TRIALS TO BOOST FERTILITY

Infertility can be a particularly difficult problem to solve for women with irregular menstrual periods, and pregnancy often remains elusive. Now, a new study at UMDNJ-New Jersey Medical School (NJMS) aims to help them.

Principal investigator Peter McGovern, MD, director of the Division of Reproductive Endocrinology and Infertility at NJMS, says that 15 to 20 percent of infertility is caused by polycystic ovary syndrome (PCOS), a hormonal imbalance that may decrease the ability of an ovary to produce an egg each month. Women with PCOS have enlarged ovaries containing numerous cysts or fluid-filled sacs. Instead of being released, the eggs form cysts on the ovary. The cysts are visible on ultrasound images and are called a "string of pearls."

PCOS is related to insulin resistance, a condition where high levels of insulin are needed to maintain normal blood sugar levels. Insulin in high levels wreaks havoc with hormones and interferes with ovulation. The new study is designed to help women with PCOS ovulate regularly and become pregnant.

Participants will be randomly placed in one of three groups. One group will take Metformin XR, a treatment for Type II diabetes, plus placebo. The second group will receive Clomiphene Citrate, a commonly used fertility medication, plus placebo. The third group will receive both medications.

"Using Metformin makes a lot of sense if you believe elevated insulin is the cause of infertility," says McGovern. Researchers believe that Metformin, which lowers insulin levels, should encourage ovulation in women with PCOS. While some physicians are using it off-label (without FDA approval for that use) to boost fertility, many are not aware of the connection between high insulin levels and lack of ovulation.

The benefits for women who enter the study include six months of infertility treatments, including medications; blood work and laboratory tests; sperm counts for the partner; a hydrosonogram (to evaluate if the fallopian tubes are open); and tests to assess ovulation, all at no cost. To be eligible, participants must be between 18 and 39 years of age, have fewer than eight menstrual periods a year, have a partner with a normal sperm count, and be willing to have sexual intercourse without contraception two to three times a week for 30 weeks.

The study is being conducted at NJMS in Newark and Hackensack University Medical Center (as well as 12 other sites across the country) with a $1 million grant from from the National Institutes of Child Health and Human Development. NJMS is one of only eight sites selected to be part of a consortium called the Reproductive Medicine Network. "This project is part of a larger NIH effort to examine PCOS by conducting several research projects, from basic science, including cell cultures and animal models, to clinical studies," says McGovern.