Study of Semaglutide Treatment to Restore Ovulation in Females Aged 12 to 35 With Obesity and Polycystic Ovary Syndrome

What this Trial Is About

This research aims to study girls and women aged 12 to 35 years with obesity and polycystic ovary syndrome PCOS, focusing on how a glucagon-like peptide-1 receptor agonist affects metabolic health, weight loss, and reproductive issues. The trial observes participants either on or off metformin to understand the link between weight loss and reproductive function, as well as how age and hormone and metabolic factors influence responses to treatment. Participants receive 10 months of semaglutide treatment, a medication given by injection, with doses gradually increased as recommended by the manufacturer up to a maximum of 1.7 mg. There are two groups one includes participants not taking metformin or hormonal therapy, and the other includes participants currently on metformin who continue their usual dose while receiving semaglutide. The study starts with a 4-month observation period before treatment. Throughout the trial, participants undergo assessments of ovulation frequency, insulin sensitivity, and ovarian shape. These evaluations happen at the start and after 10 months of treatment, with ovulation change measured over 14 months. Researchers track metabolic and reproductive changes using clinical exams, blood tests, and imaging. The total study participation lasts over a year, including observation and treatment phases, with safety and treatment effects carefully monitored.

Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome