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THE REBALANCE STUDY

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.

Age & Gender

  • 18 years ~ 40 years
  • Female

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

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.

Incentives

Up to $1350

In-person visits:
Up to 32
Phone or online visits:
Up to 10
Total length of participation:
Up to about 3 years

Looking for Specific Volunteers

Able to participate:

  • You have polycystic ovary syndrome (PCOS)
  • You are currently seeking immediate fertility
  • You have not responded to, cannot take, or have declined first-line ovulation induction treatment (such as clomid or letrozole)

Not eligible if:

  • You are currently pregnant
  • You have a BMI greater than 40
  • You have a bleeding disorder
  • You have a known previous reaction to anesthesia or sedation

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Fertility
7920 ACC Blvd. Suite 300 Raleigh, NC 27617

Additional Study Information

Principal Investigator

Anne Steiner
Center for Womens Health Research

Study Type

Clinical or Medical
Interventional

Study Topics

Women's Health

IRB Number

23-3190

ClinicalTrials.gov

NCT06206746

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