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Brief Title: The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
Official Title: A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women With Infertility Due to Polycystic Ovary Syndrome
Study ID: NCT06206746
Brief Summary: A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome
Detailed Description: The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under transvaginal ultrasound guidance to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
The IVF Center, Winter Park, Florida, United States
University of Rochester, Strong Fertility Center, Rochester, New York, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
UW Health Generations Fertility Care, Middleton, Wisconsin, United States
Name: Karl Hansen, MD, PhD
Affiliation: Oklahoma University Health Sciences Center
Role: PRINCIPAL_INVESTIGATOR
Name: Anuja Dokras, MD, PhD
Affiliation: Penn Fertility Care
Role: PRINCIPAL_INVESTIGATOR