Induction of Ovulation in Women with PCOS: Device moves to Clinical Trial Stage - Video

Physicians at the University of Oklahoma Health Sciences in Oklahoma City are leading a national clinical trial to help women with polycystic ovary syndrome (PCOS)-related infertility who want to become pregnant.

The trial, called REBALANCE, studies the safety and effectiveness of an investigational device developed by May Health that is designed to restore ovulation disrupted by PCOS.

Karl Hansen, M.D., Ph.D., chair of the Department of Obstetrics and Gynecology at the OU College of Medicine, who is leading the trial for OU, said about 80% of women with PCOS respond to oral medications designed to stimulate ovulation, and up to 50% of those women will achieve a pregnancy. However, approximately 20% of women do not begin ovulating with the medications. An alternative treatment involves gonadotropin injections, which require frequent monitoring and precise dosage adjustments. Another option, laparoscopic ovarian drilling, uses a needle-like device inserted through small abdominal incisions to deliver laser or radiofrequency energy to an ovary, aiming to restore ovulation. However, this procedure has become less common, Hansen said.

The investigational device from May Health aims to prompt ovulation in women with PCOS-related infertility through a minimally invasive outpatient procedure. The device is connected to a probe commonly used in transvaginal ultrasounds, which assesses the ovary before delivering electrothermal energy to perform the appropriate number of ablations on an ovary.

The REBALANCE trial will enroll approximately 195 patients with PCOS-related infertility at multiple sites across the United States. Researchers will assess how often women ovulate after the procedure. Secondary outcomes that will be measured include the pregnancy rate achieved after the procedure, other symptoms of PCOS, and how long the effects of the procedure endure. OU Health Sciences is co-leading the trial in conjunction with the University of Pennsylvania.

Reference: THE ULTRA TRIAL: TRANSVAGINAL ULTRASOUND-GUIDED OVARIAN ABLATION USING THE MAY HEALTH SYSTEM IN WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS)-RELATED INFERTILITY: UP TO TWELVE MONTHS FOLLOW UP, Hansen, Karl R.et al. Fertility and Sterility, Volume 120, Issue 4, e291