E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
The goal of this clinical trial is to learn if study drug exemestane will increase chances of ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS, formerly called polycystic ovary syndrome (PCOS)). It will also learn about side effects of study drug exemestane in this study population. The main questions it aims to answer are: Does exemestane lead to ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS- formerly called PCOS)? Researchers will compare exemestane to a placebo (a look-alike substance that contains no drug) to see if exemestane helps PMOS patients ovulate. Participants will: Take exemestane or a placebo every day for 5-10 days Visit the clinic three times for ultrasounds, labs, and to answer questions about side effects. If they become pregnant during this study, they will tell us how their pregnancy went after the study via a registry online.
⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Premenopausal female (ages 18-40);
• Undergone an evaluation for infertility at UNC Fertility;
• Previously diagnosed with polycystic ovary syndrome/ polyendocrine metabolic ovarian syndrome (PCOS/PMOS) via established clinical diagnostic criteria with no other identifiable cause of infertility (example- endometriosis, uterine fibroids), and recommended to begin ovulation induction therapy;
• Have patent fallopian tubes on hysterosalpingogram;
• Male partners must have a normal semen analysis if presenting with a male partner;
• Individuals must be ovulation induction naïve (no history of use of ovulation induction medications);
• Individuals must be able to read, speak, and understand English or Spanish sufficiently to provide informed consent and participate in study procedures.