Clinical Trial of Device Aims to Induce Ovulation in Women with Polycystic Ovary Syndrome

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. OU Health reproductive endocrinologist Karl Hansen, M.D., Ph.D., chair of the Department of Obstetrics and Gynecology at the OU College of Medicine, is leading the trial for OU and was the first physician in the United States to use the device.

“Polycystic ovary syndrome is a common endocrine disorder that affects about 10% of all women of reproductive age,” Hansen said, “and it is the most common cause of infertility related to the absence of ovulation. It is exciting to be studying a new potential treatment option for women with PCOS-related infertility.

“It also highlights the importance of academic medicine,” he added. “We’re not here to only provide the care that we already know; we’re here to push the envelope and develop new understandings and treatments.”

PCOS is a hormonal imbalance that occurs when the ovaries release an excess of androgens, a sex hormone that plays a central role in reproductive health. The overproduction of androgens sparks a series of events that result in irregular ovulation or the absence of it.

Hansen 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.

“We are glad to be partnering with May Health to offer this trial to patients with PCOS-related infertility,” Hansen said. “Most women with PCOS come to us because they are trying to get pregnant. For the subset of women who do not respond to oral medications, this is an exciting development to evaluate this investigational device.”

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About the REBALANCE trial

Find more information about the REBALANCE trial at this link to the federal online database of clinical research studies.