Why is this study being done?

The objective of this study is to gather data on the effectiveness and safety of the investigational Ovarian RebalancingTM procedure, to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS). The investigational procedure heats a small portion of ovarian tissue with the goal of restoring ovulation. This one-time, outpatient procedure can be performed under sedation and should take about one hour. Weekly blood tests for up to three (3) months will check for ovulation, and follow-up visits at the study center will be conducted over 36 months.

Randomized Study

Eligible participants will be randomly assigned to receive the study procedure or will be assigned to the control group. Participants assigned to the control group will be eligible to cross-over and receive the study treatment after 3 months of follow-up.

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The investigational REBALANCE Study is currently recruiting patients.

Women diagnosed with PCOS-related infertility and meeting the REBALANCE Study’s entry criteria may be eligible. Key entry criteria are women who:

  • Are between 18 to 40 years old
  • Are experiencing anovulatory infertility due to PCOS
  • Have a BMI less than 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

Clinical trial sites are currently available across the United States. More sites to be announced.

City, State :

  • San Francisco, CA – UCSF Center for Reproductive Health
  • Winter Park, FL – The IVF Center
  • Iowa City, IA – University of Iowa Hospitals and Clinics
  • Wichita, KS – Cypress Medical Research Center
  • Rochester, NY – University of Rochester, Strong Fertility Center
  • Raleigh, NC – UNC Fertility
  • Oklahoma City, OK – University of Oklahoma Health Sciences Center
  • Philadelphia, PA – Penn Fertility Care
  • Middleton, WI – UW Health Generations Fertility Care

Estimated Time Commitment for Study Participants

  • Initial Procedure: The investigational Ovarian Rebalancing procedure takes about one hour and is done in an outpatient setting under sedation.
  • Weekly Blood Tests: For up to three months following the procedure, participants will undergo weekly blood tests to monitor ovulation.
  • Follow-up Visits: There are scheduled follow-up visits at 3, 6, 9, 12, 24, and 36 months after the procedure.
  • Follow-up Calls: There will also be follow-up calls at 24 hours, 7 days, and 30 days after the procedure.

Compensation

  • Participants will be compensated for their time and travel to attend study visits.

How to Participate

Complete the prescreening questionnaire. Potentially eligible participants will be contacted with additional details.

Apply Here