A groundbreaking national clinical trial, REBALANCE, is investigating an innovative device developed by May Health to help women with polycystic ovary syndrome (PCOS)-related infertility restore ovulation. The trial, led by Dr. Karl Hansen, M.D., Ph.D., chair of the Department of Obstetrics and Gynecology at the University of Oklahoma College of Medicine, aims to evaluate the safety and effectiveness of this investigational device. Dr. Hansen was the first physician in the U.S. to use the device.
PCOS, a common endocrine disorder affecting approximately 10% of women of reproductive age, is the most frequent cause of infertility due to ovulatory dysfunction. Women with PCOS often experience hormonal imbalances, including excess androgens, which disrupt the regular release of eggs from the ovaries, leading to irregular or absent ovulation.
Dr. Hansen expressed his enthusiasm for the trial, noting the potential impact of this new treatment option for women with PCOS-related infertility. “It’s exciting to study a new potential treatment for PCOS infertility, and it highlights the importance of academic medicine,” he said. “We’re not just here to provide the care we already know; we’re here to push the envelope and develop new understandings and treatments.”
Approximately 80% of women with PCOS respond to oral medications aimed at stimulating ovulation, with up to 50% achieving pregnancy. However, for the 20% of women who do not respond to these medications, alternative treatments such as gonadotropin injections or laparoscopic ovarian drilling are sometimes considered. Gonadotropin injections, which require careful monitoring and dosage adjustments, are one option. Another, laparoscopic ovarian drilling, uses laser or radiofrequency energy to stimulate the ovaries but has become less commonly used in recent years.
The device being studied in the REBALANCE trial provides a minimally invasive alternative. The device is connected to a probe typically used in transvaginal ultrasounds to assess the ovaries. It then delivers electrothermal energy to the ovaries, performing a specific number of ablations to help restore ovulation.
The REBALANCE trial will enroll approximately 195 patients with PCOS-related infertility across several U.S. sites. The primary outcome will be the frequency of ovulation following the procedure, while secondary outcomes will assess pregnancy rates, improvements in other PCOS symptoms, and the duration of the procedure’s effects.
Dr. Hansen and the University of Oklahoma are partnering with the University of Pennsylvania to co-lead the trial. “We are glad to be partnering with May Health to offer this trial to patients with PCOS-related infertility,” Dr. Hansen said. “For women who have not responded to oral medications, this investigational device offers an exciting opportunity, and we are eager to evaluate its effectiveness.”
This national trial represents a potential breakthrough for women struggling with PCOS-related infertility, providing hope for those seeking new treatment options to restore ovulation and enhance their chances of pregnancy.
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