August 2003

Current Issue
Past Issues
About Us

Public Affairs
Baylor Home

Public Affairs
Baylor College
of Medicine
One Baylor Plaza,
Room 176B
Houston, TX 77030
Telephone:
  (713) 798-4712
Fax
   (713) 798-3692
Email: pa@bcm.tmc.edu

Comments, Suggestions?

Check out From the Laboratories, an online newsletter that focuses on research.

Trial offers hope for women with polycystic ovarian disease

By Anissa Anderson Orr and John Tyler

Sandra Carson, MD, chief of Baylor College of Medicine's IVF program, stands before the clinic's "virtual nursery" of assisted reproduction successes.

For five years, Maiyre Alfaro, age 24, unsuccessfully tried to become pregnant.

This past March, when she saw an ad for an infertility study at Baylor College of Medicine, she and her husband Jose were excited but unsure whether they wanted to try to conceive again.

“After trying for two years and not getting pregnant, I was diagnosed as having polycystic ovarian syndrome,” Alfaro said. “We went to an infertility specialist for two years and nothing ever happened. Then somehow I got pregnant on my own, but I miscarried. When we saw the ad, my husband and I went back and forth on whether to start over. But something inside me said this is our last chance. Let’s do it.”

A month after enrolling in the study that involves drugs already used in the treatment of polycystic ovarian syndrome and infertility, Alfaro received some surprising news from study coordinator Missy Torres following a routine blood test.

“She said, ‘Congratulations, you are pregnant,’ and I said, ‘Are you sure?’ I was trying not to set myself up for disappointment. After that I went to the store to get a pregnancy test and bought three of them. Every one was positive.”

Now that she is 13 weeks pregnant, Alfaro and her husband are relishing the roles of expectant parents.

“I just can’t tell you how happy I am,” Alfaro said. “I am so grateful for having another chance.”

Hormonal imbalance causes infertility

Polycystic ovarian syndrome is a leading cause of infertility and affects an estimated 5 million, or 10 percent, of U.S. women. The syndrome causes hormone imbalances that lead to irregular menstrual cycles, excess facial and body hair, weight gain and adult acne.

“Getting pregnant is a frustrating experience for women with polycystic ovarian syndrome,” said Sandra Carson, MD, a principal investigator for the study and a professor of obstetrics/gynecology at Baylor. “Often, they have been trying to get pregnant for some time and are unsuccessful or they have been told that they cannot become pregnant at all.”

Trial tests combination approach

In a study designed to determine how best to help women with polycystic ovarian syndrome overcome their infertility problem, Carson and her colleagues are attempting to determine whether drugs used now alone are more effective when they are combined. In the study at Baylor, women are assigned at random to one of three medication groups. One group is given metformin XR and placebo (a non-active pill). The second group takes clomiphene citrate and placebo, and the third, metformin XR and clomiphene citrate together. Neither the women nor their physicians know which group each woman is in. This kind of study is called double-blind and eliminates any bias on the part of the physicians or subjects.

Metformin is commonly used to treat insulin resistance in diabetes and has been used to treat infertility in women with polycystic ovarian syndrome since the 1990s. Clomiphene citrate, also known as Clomid, is the standard treatment for infertility for women with this disorder.

Two pregnancies, including Alfaro’s, have already occurred in the study, although these women do not know which drug or if a combination of the drugs is what helped them achieve pregnancy, Torres said. More than 500 calls have come in to date, but Baylor is still screening women to participate in the study.

Baylor is one of 13 medical centers across the United States recruiting participants for the study sponsored by the National Institute of Child and Human Development, a division of the National Institutes of Health. The study is testing a combination of medications to see which one best encourages ovulation in women with polycystic ovarian syndrome.

Women who qualify for the study will receive free study medications, blood tests performed after enrollment in the study, a physical exam including an ultrasound of the ovaries, a pregnancy test and an ultrasound if they become pregnant.

The study will also determine whether multiple births result from use of the drugs, a known problem with clomiphene, and if any of the therapies reduce the possibility of an early miscarriage, a common problem for women with polycystic ovarian syndrome.

For information on enrollment call 713-798-7549.

© Copyright 2002 - 2003 Baylor College of Medicine. All Rights Reserved.