To test the safety and effectiveness of the May Health System to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to clomid or letrozole treatment.
After consent, participants will complete a baseline visit to confirm eligibility. If eligible, participants will be randomized into the Device Arm or the Control Arm. All participants will complete questionnaires, physical exams, blood work, and transvaginal ultrasounds. The Device Arm will receive the May Health procedure and then regular blood tests. There will be 6 follow up visits and some follow up calls through 36 months after the procedure. The Control Arm will complete regular blood tests then meet with the study team at Month 3 to either exit the study or to crossover into the Device Arm to receive the May Health procedure.
Up to $1350
UNC Fertility
7920 ACC Blvd. Suite 300 Raleigh, NC 27617
Anne Steiner
Center for Womens Health Research
Clinical or Medical
Interventional
Women's Health
23-3190