The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

The REBALANCE Study is looking at a new way to help women with Polycystic Ovary Syndrome (PCOS) have babies. PCOS is a condition where the ovaries don’t work properly, making it hard for women to get pregnant. The study is testing a procedure called transvaginal ablation, which involves using a special tool through the vagina to treat the ovaries and help them work better. This is done with the help of an ultrasound, which is like a video image of the inside of the body, to guide the procedure.

Women aged 18-40 who have tried other treatments without success, or who cannot or choose not to try them, may join. The study requires participants to have at least one working fallopian tube and normal uterus.

• The study involves multiple visits and follow-up evaluations.
• Participants will receive treatment as part of the study.
• There may be some risks due to the procedure and follow-up requirements.

Women cannot participate if they are pregnant, have certain health conditions, or are part of another study. Participants need to speak the language of the consent form and agree to the study rules.