The REBALANCE Study
PCOS is caused by a hormone imbalance which can affect the menstrual cycle. The REBALANCE Study is evaluating the safety and effectiveness of an investigational procedure called Ovarian Rebalancing, intended to help women ovulate. The procedure is a one-time, outpatient procedure performed using pain medication and sedation and should take about one hour. The procedure uses radiofrequency energy to gently heat a small portion of the ovarian tissue responsible for hormone production, which is intended to help with ovulation. Key entry criteria are women who: Are between 18-40 years old Are experiencing an ovulation infertility due to PCOS Have a BMI <40 Have had no clinical response to ovulation induction treatment such as letrozole or clomiphene citrate or are contraindicated for or decline such treatment Are currently seeking immediate fertility Some participants will be part of a control group who will receive no treatment. Participants who are randomly assigned ...