Why is this study being done?
The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under transvaginal ultrasound guidance to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.
Who may participate?
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.
