Press Release

For Immediate Release
Contact: Kaylyn Kendall Dines
(973) 972-7276

At UMDNJ-New Jersey Medical School
$1 Million Grant Awarded to UMDNJ for a National Study on Women Seeking Pregnancy

Women who would like to become pregnant, but have irregular menstrual cycles, are eligible to participate in a study at the University of Medicine and Dentistry of New Jersey (UMDNJ) to identify effective treatments for restoring ovulation and fertility.

Health care professionals at UMDNJ-New Jersey Medical School, Newark, and Hackensack University Medical Center will conduct this 30-week, nationwide study that will offer treatment for symptoms related to Polycystic Ovary Syndrome (PCOS), a hormonal imbalance that may decrease the ability of an ovary to produce an egg each month.

Dr. Peter McGovern, director of the Division of Reproductive Endocrinology and Infertility at the UMDNJ-New Jersey Medical School and the principal investigator, said, "Statistics show that 20 percent of infertility is caused by Polycystic Ovary Syndrome."

PCOS occurs when a woman's ovaries are enlarged and contain numerous cysts or fluid-filled sacs. Symptoms of this disorder may include fewer than eight menstrual cycles per year, excess insulin, obesity, acne and high levels of androgen, a male hormone that often produces facial hair.

To be eligible for the study, participants must be between ages 18 and 39, have fewer than eight menstrual cycles per 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.

Prior to acceptance into the study, each woman will receive a comprehensive physical examination. During the study, each patient will be responsible for maintaining a daily journal and taking prenatal vitamins or folic acid to help prevent birth defects. During the study, participants will schedule monthly visits to review or alter medication levels and discuss daily journal entries.

The women who are enrolled in this double-blind study will be randomly placed in one of three groups. The study will compare the individual effectiveness of two new medications with a combination treatment to improve ovulation. Women in one group will receive Metformin XR, originally manufactured by Bristol Myers Squibb, and a placebo, a pill with inactive ingredients. Researchers believe Metformin XR, which has been approved by the federal Food and Drug Administration to treat individuals with Type II diabetes, will decrease high levels of insulin often found in women with PCOS and encourage ovulation.

The second group will receive Clomiphene Citrate, a common fertility medication that is manufactured by Teva Pharmaceuticals and a placebo. Clomiphene Citrate is an oral medication that has been approved by the FDA for Polycystic Ovary Syndrome. By blocking the estrogen receptor, this medication causes the body to produce more hormones, resulting in egg production. Women in the third group will take both Metformin XR and Clomiphene Citrate.

Dr. Gerson Weiss, co-investigator and chair of the Department of Obstetrics and Gynecology at the UMDNJ-New Jersey Medical School, said, "Both UMDNJ-New Jersey Medical School and Hackensack University Medical Center are proud to be recipients of a $1 million grant from the National Institutes of Child Health and Human Development for this study. We are also honored to be among nine sites that were selected as members of a prestigious Reproductive Medicine Network which developed the protocol for this study."

For more information about the Polycystic Ovary Syndrome study, contact Amy Solnica, RN, at 201-393-7430 or toll free at 1-888-777-8922 ext. 7430.

The UMDNJ-New Jersey Medical School is one of three medical schools of the University of Medicine and Dentistry of New Jersey (UMDNJ). UMDNJ comprises New Jersey's three medical schools, the state's only dental school, a nursing school, a graduate school of biomedical sciences, a school of health related professions and a school of public health on campuses in Newark, Piscataway/New Brunswick, Scotch Plains, Camden and Stratford. UMDNJ also operates University Behavioral HealthCare in Newark and Piscataway. It is affiliated with more than 200 health care and educational institutions throughout the state.

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