Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome

What Was Tested

This registered phase 4 trial tested Semaglutide for pcos.

All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination.

All subjects will be followed up for 24 weeks for pregnancy outcome.

It had three arms (groups): metformin (active comparator), semaglutide (experimental) and semaglutide and metformin (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

After 12 weeks of treatment, all subjects will stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination.

All subjects will be followed up for 24 weeks to evaluate the fertility related indicators.

Who Took Part

Enrollment: 75 planned participants were the target.

It was open to women only aged from 22 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Meet the PCOS diagnostic criteria (Rotterdam）. BMI ≥ 28 kg/m2. Infertility: having normal sexual life and failing to conceive without contraception for more than 1 year. Willing to be pregnant, and her husband has no serious infertility.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: history of acute pancreatitis, individual or family history of medullary thyroid cancer and multiple endocrine adenomas; type 1 diabetes and special type diabetes; history of tumor.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The pcos participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2023-05-09 with completion listed for 2024-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage change in bodyweight at 12 weeks for semaglutide versus metformin (time frame: at the end of 12 weeks of treatment).

It also tracked 4 secondary outcomes, for example HOMA-IR at 12 weeks of treatment, testosterone level at 12 weeks of treatment, androstenedione level at 12 weeks of treatment and FAI (Free Androgen Index) at 12 weeks of treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 75 people with pcos.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, PCOS research.