By Dr. Lauren Roth, Advanced Reproductive Medicine
Advanced Reproductive Medicine was part of the NIH team proving that a new drug results in a 45 percent increase in pregnancy for women with the leading cause of infertility.
DENVER (July 11, 2014) – The July 9 issue of The New England Journal of Medicine brought international attention to the groundbreaking research on a new drug for women with polycystic ovary syndrome (PCOS) that featured clinical trial work by University of Colorado Advanced Reproductive Medicine (UCARM). Thirty-one Colorado women with PCOS who participated in the study became pregnant after taking the drug Letrozole.
“Publication of this study in The New England Journal of Medicine is very gratifying on a professional level for our department and for the University,” said Dr. Ruben Alvero, UCARM’s director and one of the principal investigators on this National Institutes of Health (NIH) study.
“But of greater importance is that as more doctors learn of the significant improvements from Letrozole and prescribe it for their patients, more women who thought they couldn’t have children will become mothers,” said Alvero.
As many as 10 percent of women of childbearing age have PCOS, or 6.1 million in the U.S. PCOS is a hormone imbalance problem that can interfere with normal ovulation. Its cause is unknown but it is the most common hormonal abnormality in reproductive age women and a principal cause of female infertility.
In 2011 Jessica Edwards of Denver participated in the clinical trial at UCARM, which began in 2009. She and her husband, Orlando, didn’t know at the time which drug she was taking, but they found out later it was Letrozole.
“We started the trial and two months in, we were pregnant,” said Edwards, who had been trying to get pregnant for five years. “We’re very grateful for the clinical trial at Advanced Reproductive Medicine. Without Letorzole, we wouldn’t have our daughter Lilla.”
The first line therapy for PCOS has always been Clomiphene citrate, and nearly half of women with PCOS who take it get pregnant. But Letrozole is 45 percent more effective than Clomiphene, according to Alvero.
And that’s a huge advancement in infertility treatment. Letrozole is inexpensive compared to many infertility treatments. The drug was found to increase ovulation and improve the chances of successful pregnancy after ovulation. Letrozole also has fewer side effects than Clomiphene.
Eighty-five women with PCOS in Colorado took part in the randomized control trial, the first scientifically rigorous study to prove the significant benefit of Letrozole for women with PCOS. Letrozole is primarily used in breast cancer treatment and is a relatively new drug in the area of ovulation induction.
CU’s Advanced Reproductive Medicine was one of seven sites nationwide participating in this trial of the NIH’s Reproductive Medicine Network (RMN). RMN facilitates diagnostic solutions to reproductive problems by maintaining a clinical research network of sites to find answers to important clinical problems more rapidly than individual sites acting alone. The University of Colorado department bested many other applicants nationwide in the grant process.