The REBALANCE Study is here.
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 < 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.
Why Are We Doing This Study?
The purpose of this study is to gather evidence for the safety and effectiveness of an investigational medical device called the System for the treatment of infertility in women with polycystic ovary syndrome who have not responded to a high dose of first-line ovulation induction medication or are contraindicated for or decline such treatment.
What to Expect During the Study
This one-time, outpatient investigational procedure performed with the May Health System using pain medication and sedation should take about one hour.
Screening
Confirm eligibility
Day of procedure
Transvaginal (via the vagina) ultrasound guidance is used to visualize the ovary.
A thin needle is then inserted through the vaginal wall and into the ovary, similar to the technique routinely used for egg retrieval for IVF. Radiofrequency energy is then delivered to gently heat the surrounding ovarian tissue.
After procedure
Weekly blood tests up to 3 months to check for ovulation
Follow up calls: 24 hours, 7 days and 30 days after the procedure
Follow up visits at the study center: 3, 6, 9, 12, 24, and 36 months after the procedure
Some participants will be part of a Control group who will receive no treatment. Participants who are randomly assigned to the Control group have the option to undergo the investigational Ovarian Rebalancing procedure after their 3-month follow-up visit and will follow the same schedule for follow-up as described above.
The Ovarian Rebalancing procedure is currently investigational.