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.
Study Title
The REBALANCE Study
Study Description
The objective of this study is to gather data on the effectiveness and safety of the investigational Ovarian RebalancingTM procedure, designed to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS). This one-time, outpatient intervention is performed under sedation and takes about one hour. Weekly blood tests for up to three months will monitor ovulation, followed by follow-up visits over 36 months.
Eligible participants will be randomly assigned to receive the study procedure or to a control group, with the option to cross-over after 3 months of follow-up.
Eligibility Criteria
You can participate in this study if you:
- 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
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: Approximately one hour in an outpatient setting under sedation.
- Weekly Blood Tests: Up to three months of weekly tests to monitor ovulation.
- Follow-up Visits: Scheduled at 3, 6, 9, 12, 24, and 36 months.
- Follow-up Calls: At 24 hours, 7 days, and 30 days post-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.
Principal Investigators
Karl Hansen, MD, PhD, Oklahoma University Health Sciences Center
Anuja Dokras, MD, PhD, Penn Fertility Care
For More Information About This Study
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 does not recommend or endorse any specific studies, tests, physicians, products, procedures, opinions, or other information from third parties that may be mentioned in PCOS Challenge communications or on our websites. Any such mention is for informational purposes only. Third party services, products, and websites are the sole responsibility of their providers. PCOS Challenge, Inc. makes no warranty regarding third party information and accepts no liability for any claims, errors, or omissions. Read Full Disclaimer.