For Immediate Release
Contact: Kaylyn Kendall Dines
At UMDNJ-New Jersey Medical School
Researchers at UMDNJ Seek Women for Study Comparing Infertility
Researchers at the University of Medicine and Dentistry of New
Jersey (UMDNJ) are seeking volunteers for a study comparing treatments
for infertility in women who have Polycystic Ovary Syndrome (PCOS).
The purpose of the study, which is funded by the National Institute
of Child Health and Human Development, is to compare the effectiveness
of traditional infertility treatments with Metformin, a medication
used to treat Type 2 diabetes.
The UMDNJ-New Jersey Medical School and University Reproductive
Associates in Hasbrouck Heights are the only two sites in the
metropolitan New York area participating in the 30-week study.
In polycystic ovary syndrome, an excess of male hormones interferes
with normal ovulation and other body systems. Ovarian cysts form
and enlarge the ovaries. In addition to infertility, polycystic
ovary syndrome symptoms can include irregular menstrual periods,
excessive body and facial hair, acne, and obesity, with weight
concentrated around the abdomen.
Five to 10 percent of women of reproductive age have polycystic
ovary syndrome. This medical illness often begins in childhood,
but is sometimes undiagnosed until adulthood when women fail to
Dr. Peter McGovern, director of the Division of Reproductive
Endocrinology and Infertility at the UMDNJ-New Jersey Medical
School and principal investigator of the study, said, "The objective
of this study is to better understand polycystic ovary syndrome
and identify the most effective way to treat PCOS-related infertility.
Metformin has shown promise in treating polycystic ovary syndrome-associated
infertility. This nationwide study is large enough to determine
if that promise is warranted."
To be eligible for the study, participants must be between ages
18 and 39, have fewer than eight menstrual cycles per year, and
have a partner with a normal sperm count.
Participants in the study will be assigned to one of three groups
and randomly assigned to receive one of three treatments. In one
group, women will receive both metformin and clomiphene citrate,
a drug that stimulates ovulation. The second group will receive
a placebo and metformin, while the third group will receive a
placebo and clomiphene citrate.
Women with untreated PCOS are at increased risk for diabetes,
heart disease, high blood pressure, and cancer of the endometrium
(the lining of the uterus). In addition to weight-loss and weight-loss
management programs, current treatments for PCOS include oral
contraceptives, which regulates the menstrual cycle.
Research indicates an abnormality in how the body uses insulin
may account for many symptoms associated with this disorder.
"Women with PCOS tend to produce higher levels of insulin, which
may affect their ability to ovulate," Dr. McGovern said. "Since
Metformin lowers insulin levels, it also may improve their chances
Dr. Gerson Weiss, co-investigator and chair of the Department
of Obstetrics and Gynecology at the UMDNJ-New Jersey Medical School,
said, "We, at the UMDNJ-New Jersey Medical School, are proud to
be recipients of a $1 million grant from the National Institutes
of Child Health and Human Development for this study."
The University of Medicine and Dentistry of New Jersey (UMDNJ)
is one of a dozen sites. The other sites are: Penn State College
of Medicine at Penn State in Hershey, Pa.; Baylor College of Medicine
in Houston; the University of Pennsylvania in Philadelphia; the
University of Alabama at Birmingham; the University of Colorado
at Boulder; the University of Texas Southwestern Medical Center
at Dallas; Wayne State University in Detroit; the University of
California at San Diego; the University of California at San Francisco;
Stanford University in Palo Alto, Calif.; Virginia Commonwealth
University in Richmond; and the University of Pittsburgh in Pa.
For more information about the polycystic ovary syndrome study,
contact Amy Solnica, RN, at 973-972-3633.