June marks World Infertility Month, raising awareness about infertility, a challenge that impacts both men and women globally. In the United States, approximately 13.4% of women of reproductive age experience difficulties in conceiving or maintaining pregnancy.
A significant factor contributing to infertility among women is polycystic ovary syndrome (PCOS). Aiming to address this issue, a national trial at OU Health intends to provide new solutions for women facing complications due to this condition.
Lexy Burnett, a mother of twin girls, reflects on her own difficult path to motherhood. “My cycles were incorrect. I didn’t know what PCOS was at that time,” she recounted. After stopping birth control, she suspected a larger problem and underwent testing, which led to her PCOS diagnosis following several unsuccessful attempts with oral medication designed to stimulate ovulation.
According to Karl Hansen, an infertility specialist, “Polycystic ovary syndrome is one of the most common endocrine disorders that affect women.” Affecting up to 10% of women of reproductive age, PCOS is known for irregular ovulation. Although the exact cause remains unclear and no definitive cure exists, management strategies can be tailored based on individual patient goals. “Oral contraceptive pills are a great option, but obviously, that wouldn’t help someone who wants to become pregnant,” Hansen added.
Irregular ovulation is the primary challenge women face when trying to conceive. While oral medications are typically the first line of treatment, Hansen informed that “about 20% of women with polycystic ovary syndrome don’t respond to these oral medicines and don’t ovulate.” As treatments become more advanced, options like injections, intrauterine insemination, or in vitro fertilization come into play. “Those are expensive. They’re difficult to manage. They require frequent office visits,” Hansen noted.
To pave the way for innovative treatments, the Rebalance trial, led by Dr. Hansen, seeks to change the landscape of PCOS management. This research involves a device designed to restore ovulation through an office-based procedure known as ovarian ablation. “That allows us to do the procedure and offer it more widely,” Hansen said.
A pre-trial conducted two years ago at OU was the first site in the U.S. to test this procedure, involving five patients locally and 25 across Europe. The results were promising, revealing that “ultimately, a little more than 40% of patients in the study achieved a pregnancy,” Hansen stated.
Another participant from the pre-trial, Veronica, shared her success story: “So after four years of trying, I want to introduce Eliahana. This is really big. We’re so happy,” she expressed, emphasizing the emotional weight of her journey. Remarkably, around 60% of women in the pre-trial began ovulating independently after undergoing the procedure.
The national Rebalance trial aims to enroll 195 women throughout the U.S., monitoring various factors such as pregnancy rates, ovulation, and hormonal changes over a span of three years. Hansen conveyed optimism about the project’s potential: “I think it represents a real advance in our ability to treat patients with ovulatory disorders.”
For countless women facing the trials of PCOS, the Rebalance trial offers a glimmer of hope. Burnett articulated a common sentiment: “If I didn’t have to go through all those shots, all those pills, it would have probably saved a lot of emotional exhaustion and the emotional roller coaster.” Ultimately, the goal of Rebalance is to provide women with less invasive solutions to restore their reproductive health.
