Middleton

Researchers are evaluating the May Health System, a device used for transvaginal ablation of ovarian tissue under ultrasound guidance, to restore ovulation in women with infertility caused by polycystic ovary syndrome (PCOS). This study focuses on women who have not responded to first-line ovulation induction treatments or cannot use them due to contraindications or personal choice. The trial aims to provide evidence for the safety and effectiveness of this approach in improving ovulation and fertility outcomes. The study includes two groups: one receiving the May Health procedure, which involves using a special needle-catheter device guided by ultrasound to deliver radiofrequency energy to ablate ovarian tissue, and a control group receiving no fertility medication. Participants who do not become pregnant after three months may cross over to receive the device treatment and follow the same monitoring schedule. The procedure is done under conscious sedation and involves close ultrasound visualization. Participants will be involved in follow-up visits for up to 36 months to monitor ovulation occurrence, pregnancy, hormone levels, pain after the procedure, and recovery activities. Researchers will also collect safety data throughout this period. Various assessments include timing ovulation, measuring hormone serum concentrations, and evaluating post-procedure pain and daily activity performance. The study helps track both short-term and long-term outcomes related to fertility and safety.