Two families overcome infertility through research
Ashley Abeyta and her husband Mike had been trying for two years to get pregnant with no luck, though luck had nothing to do with it. Ashley has polycystic ovary syndrome (PCOS), a condition in which abnormal cysts in the ovaries interfere with ovulation. No ovulation, no eggs, no baby.
Ashley was not alone. An estimated 10 percent of reproductive age women have PCOS, affecting approximately six million women in the U.S. alone. PCOS is a leading cause of infertility. Yet, having company in misery didn’t really make Ashley feel any better, and she often felt miserable.
Then one day, an email popped up on her computer that changed her life.
“I had been diagnosed with PCOS, and I tried diet and nutrition changes, but it wasn’t working,” recalls Ashley, who had also taken the drug metformin for PCOS symptoms. “I was having emotional issues, it was just so draining. And then the notice about the PCOS clinical trial came up on my computer screen in an email from University of Colorado Advanced Reproductive Medicine.”
Advanced Reproductive Medicine was one of seven sites around the country conducting research trials for the National Institutes of Health (NIH) on a promising new drug that appeared to have the potential to help many women with PCOS overcome infertility. As a University of Colorado employee, Ashley received an email recruiting women with PCOS for the study. She and Mike decided to give it a try and she was accepted into the trial.
From trying to crying
Eighty-five women participated in the Colorado section of the study that began in 2009. This was the first large, double blind, randomized trial comparing Letrozole with Clomiphene in PCOS patients with irregular ovulation. One set of women took Clomiphene, one set took Letrozole. Clomiphene (clomid) was the gold standard of treatment and Letrozole, a drug developed to treat breast cancer, was being used for PCOS but had never been fully tested for its effectiveness.
Neither the participants nor the clinicians knew which drug was being taken (hence the term double blind). Meticulous records were kept, however, to track which patients on what medication had what results. About 660 women nationwide took part in the study.
One of those women was Jessica Edwards of Denver, who also had PCOS. She and her husband Orlando had been trying to get pregnant for five years.
“It was definitely wearing on us,” says Jessica. “We finally came to the conclusion that if it happens, it happens.”
But it wasn’t happening – until the day they were talking to Dr. Patricia McShane at Advanced Reproductive Medicine about the drug clomid.
“She knew about our medical history and told us about the clinical trial,” says Jessica. “They did some tests, and I became part of the study. They gave me pills to take for a month. When I returned with the empty container, I got more. I had no idea what I was taking.”
What she was taking didn’t take long. Two months into the trial, she became pregnant.
“Orlando didn’t believe it at first,” says Jessica. “I told him on our anniversary, and he said, ‘No!’ I said Yes. We were so excited, and very happy.”
After five years of trying, Jessica and Orlando were on the way to being parents—after only two months in the trial. It was a fast turnaround, but not as fast as Ashley’s.
“I had been taking the medication for just one month when I took a pregnancy test at home,” recalls Ashley. “I knew it was too early, and thought that my heart would sink—but it was positive! And when I had the blood work done it was positive. I was shocked. It was unreal at that point; everything seemed to stop.”
But not for long. She called her mom; her husband Mike called his mom, sharing their great news.
“I was on the phone with my mom crying: ‘I’m pregnant—I can’t believe it!’ Then I called my best friend: ‘Oh My Gosh, I’m having a baby!’ We had our friends over for a dinner party and celebrated my pregnancy,” says Ashley. “Our family and friends were our support group through all those times we were trying to get pregnant.”
Ashley and Jessica weren’t the only happy participants in the CU clinical trial. More than 30 Colorado women became pregnant taking Letrozole, and quite a few others taking Clomiphene. In the trial Letrozole was proven to be 45 percent more effective than Clomiphene, which means that potentially millions of women with PCOS who couldn’t get pregnant before now have a much better chance.
This seven-site NIH study won the Scientific Program Prize Paper award presented by the Conjoint Meeting of the International Federation of Fertility Societies and the American Society for Reproductive Medicine in October 2013. Dr. Ruben Alvero, director of CU’s Advanced Reproductive Medicine and the site principal investigator in the study, is proud of the department’s research and its award.
“But more importantly, it shows how we are constantly trying to improve outcomes for our patients facing fertility issues,” says Alvero. “Our physicians and staff are always trying to do things better. And this research is a true breakthrough in fertility medicine.”
Ashley and Jessica are certainly glad about that. But not as glad as they are about Dominic, Ashley’s three-year-old son, and Lilla, Jessica’s two-and-a-half-year-old daughter.
“Going through so many different things to have a child makes you appreciate her more, I think,” says Jessica. “Realizing what we had to go through, what we did to have her – she’s a miracle.”
Letrolzole, which she recently found out was the medication she received in the trial, was a big part of helping that miracle happen. She’ll still need help getting pregnant a second time, and Jessica says she knows what she’ll do. “It’ll be Letrozole.”
Ashley still doesn’t know which drug she took, but she is so glad to have received that email about the clinical trial. After her experience, she’s recommended clinical trials to family members and friends who need help conceiving. And one family member has gotten pregnant in another CU clinical trial involving in vitro fertilization (IVF).
“The clinical trial program at Advanced Reproductive Medicine is amazing. The communication I got was wonderful,” says Ashley. “Mallary Crow (research assistant) was so excited for me when I got pregnant. When you join the study, you give them information about yourself, so she knew how emotionally draining the process had been for me. They were great.”