Physicians at the University of Oklahoma (OU) Health Sciences and the University of Pennsylvania are co-leading a national clinical trial to investigate a novel device for women with polycystic ovary syndrome (PCOS) struggling with infertility. The REBALANCE trial aims to determine if the device can safely and effectively induce ovulation through a less invasive ablation procedure.
PCOS, a hormonal disorder affecting approximately 10% of reproductive-age women, is a leading cause of infertility. Current treatments range from oral contraceptive pills for symptom management to more invasive methods like in vitro fertilization (IVF). According to Dr. Karl Hansen, chair of the Department of Obstetrics and Gynecology at the OU College of Medicine, a significant gap exists in the care pathway for women who do not respond to oral medications but are not yet candidates for IVF.
Device Details and Trial Design
The investigational device, developed by May Health, connects to a probe commonly used in transvaginal ultrasounds. It allows physicians to deliver a pre-calculated amount of electrothermal energy to the ovary, based on its volume. This approach differs from the more traditional laparoscopic ovarian drilling, which involves inserting a needle-like device through small abdominal incisions to deliver laser or radiofrequency energy to the ovary.
The REBALANCE trial will enroll approximately 195 patients with PCOS-related infertility across multiple sites in the U.S. Participants will be randomized into two groups: one receiving immediate treatment with the device and the other serving as a control group for the first three months. After three months, patients in the control arm will have the option to cross over and receive the device treatment. Researchers will monitor participants regularly for signs of ovulation.
Endpoints and Potential Impact
The primary outcome of the trial is the induction of ovulation. Secondary outcomes include pregnancy rates achieved post-procedure and the duration of the device's effects. The study aims to provide a less invasive and more targeted treatment option for women with PCOS-related infertility, potentially reducing the need for more complex and expensive procedures like IVF. Hansen emphasized the importance of advancing the standard of care through research and investigation, highlighting the potential of this study to improve outcomes for patients with PCOS.
