Monday, October 28, 2003

DCRI Study Seeks Aid For Infertile Women
By Mike Upchurch

Many of the clinical trials conducted by the DCRI have the necessary but grim endpoint of mortality. One, however, is measuring the effectiveness of a drug by its ability to bring new lives into the world. The Pregnancy in Polycystic Ovary Syndrome (PPCOS) trial may offer hope to the thousands of women who cannot realize their dreams of motherhood because of this disease.

Polycystic ovary syndrome affects 5%-10% of women of reproductive age and is a leading cause of infertility. In PCOS, a hormonal imbalance causes irregular ovulation, typically accompanied by multiple cysts in the ovaries. Other symptoms that make up the syndrome can include weight gain, acne, hair growth, and insulin resistance.

This last symptom may be the key to treatment of PCOS. Existing research suggests that using metformin, a drug commonly given to diabetics, can help regulate menstruation and perhaps increase the chances of pregnancy usually dampened by PCOS.

Insulin resistance, an inability of the body to properly control the level of sugar in the blood, is a prime contributor to PCOS-related infertility and a precursor to diabetes. The researchers conducting the PPCOS trial hope that metformin's ability to reduce insulin resistance will help young women rendered infertile by PCOS to become pregnant.

Increasing insulin sensitivity can improve the reproductive consequences of PCOS, and metformin is often prescribed "off-label" for this use. Since metformin is not currently labeled as a treatment for women with PCOS and has not been studied in combination with other drugs, as it will be in this study, PPCOS is considered a Phase III trial. The IND for the study is held by the sponsoring agency, the National Institute of Child and Human Development (NICHD), part of the National Institutes of Health.

The PPCOS study will enroll 678 women with polycystic ovary syndrome who have 8 or fewer menstrual cycles per year, who are otherwise in good health, and who wish to become pregnant. Enrollment began in November of last year and 234 patients are enrolled as of today.

All patients are randomized to receive metformin, a commonly used infertility drug called clomiphene citrate, or a combination of the two. They are followed for 30 weeks, until they have 6 cycles with normal ovulation, or they become pregnant. This is the first DCRI trial to have live birth as its endpoint and may represent the only chance at pregnancy for many of its patients. The first live birth of the study occurred on October 9th.

The DCRI serves as the data coordinating center for the PPCOS trial. Dr. Evan Myers is the principal investigator and Lindsay Lambe is the project lead. Rebecca DeWire is serving dual roles as clinical monitor and site manager. The data are managed by Deb Mark, who works closely with trial statistician Hongqui Yang.

The PPCOS study is being administered through the Reproductive Medicine Network (RMN). The RMN is an 8-center consortium of research institutions, coordinated by the DCRI, which conducts controlled clinical trials of new therapies for reproductive illnesses affecting both women and men.

For more information on the RMN, as well as the Pregnancy in Polycystic Ovary Syndrome trial, visit the RMN web site here.