PCOS Challenge: The National Polycystic Ovary Syndrome Association

The REBALANCE Study

This study is not affiliated with PCOS Challenge, Inc.
The announcement below is being provided for informational purposes only.*

PCOS REBALANCE Study Logo

The Investigational REBALANCE Study for
PCOS-Related Infertility Is Now Enrolling
Women with Infertility Due to
Polycystic Ovary Syndrome

Participants will be compensated for
their time and travel to attend study visits.
See Below for Details and Eligibility Criteria

Study Title

The REBALANCE Study

Study Description

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 Ovarian Rebalancing procedure heats a small portion of ovarian tissue with the goal of restoring ovulation. This one-time, outpatient investigational procedure, can be performed under sedation, and should take about one-hour. Weekly blood tests 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 received the study treatment after 3 months of follow-up.

Eligibility Criteria

  • 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
 PCOS REBALANCE Study

Trial Site Locations

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
  • Charlotte, NC – Reach Fertility
  • Raleigh, NC – UNC Fertility
  • Oklahoma City, OK – University of Oklahoma Health Sciences Center
  • Saint Louis, MO – Washington University Fertility and Reproductive Medicine Center
  • Hershey, PA – Penn State College of Medicine
  • Philadelphia, PA – Penn Fertility Care
  • San Antonio, TX – UT Health San Antonio
  • Temple, TX – Baylor Scott & White Medical Center
  • 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

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

Principal Investigators

  • Karl Hansen, MD, PhD, Oklahoma University Health Sciences Center
  • Anuja Dokras, MD, PhD, Penn Fertility Care

For More Information About This Study

Apply for Research Study

CAUTION:
Investigational device.
Limited by United States law to investigational use.
Exclusively for clinical investigations.

*Disclaimer

This study is not affiliated with PCOS Challenge, Inc. PCOS Challenge, Inc. does not recommend or endorse any specific studies, tests, physicians, products, procedures, opinions, or other information from third parties that may be mentioned on the PCOS Challenge websites. Any such mention is for information purposes only. Any third-party services, products and websites, including those offered by affiliates, sponsors and advertisers, which may be accessed through the PCOS Challenge websites are the sole responsibility of the third party who is offering the service, product or posting the website. PCOS Challenge, Inc. makes no warranty as to the accuracy of any information on third-party websites and accepts no liability for any claims, errors, and omissions or for any damage or injury to persons or property arising out of the use or operation of any services, products, materials, instructions, methods, ideas or procedures provided by third parties. Any offers, pricing, and/or promotions offered through the PCOS Challenge websites, affiliates, or any third party are subject to change without notice at the sole discretion of the party making the offer. Read Full Disclaimer.
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  • The REBALANCE Study
    The REBALANCE Study

    The REBALANCE Study for PCOS-related infertility is now enrolling women with PCOS and anovulatory infertility. Participants will be compensated for their time and travel to attend study visits.

REBALANCE Study for PCOS-Related Infertility
The REBALANCE Study
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