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.
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;
Under 18 or over 40 years of age; Individuals without the diagnosis of PCOS;
Body mass index >40 kg/m²; Abnormal hysterosalpingogram;
Abnormal semen analysis if presenting with a male partner;
History of ovulation induction medication use;
Parallel
Exemestane 25 MG
DrugExperimental Drug
Placebo
DrugPlacebo drug that patients in placebo arm will take
Exemestane 50 MG
DrugOne study arm with take two tablets for 5 days (50mg per day)
Number of participants with study-defined positive progesterone levels on Day 21
The primary outcome of this study will be positive day 21 progesterone levels (positive level \>/= 3 ng/mL).
Number of follicles greater than 10 millimeters
Mid-follicular ultrasound where ovarian follicles are measured for diameter. Any follicle with diameter \>10mm will be reported.
Mean Diameter of All Follicles >10mm
During mid-follicular ultrasound- all ovarian follicles are measured for diameter. All follicle diameters greater than 10mm in average will be reported with size reported.
Endometrial thickness in millimeters measured by mid-follicular ultrasound
During mid-follicular ultrasound, a single image of endometrial thickness will be acquired during mid-follicular measurement, and reported in size of millimeters.
Percentage of participants with a positive human chorionic gonadotropin (hCG) result
Percentage of participants who initiated treatment that report a positive human chorionic gonadotropin (hCG) level, as verified with hCG laboratory measurement.
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