Liraglutide Treatment in Obese Infertile PCOS Women

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide for pcos.

Polycystic ovary syndrome (PCOS) is the main cause of female anovulatory infertility, and it is also a high-risk group of obesity.

It had two arms (groups): Intervention Group (experimental) and Control Group (active comparator).

The registry classes the interventions as drug.

Who Took Part

890 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Women with polycystic ovary syndrome (PCOS) who meet the Rotterdam diagnostic criteria. Aged 20-40 years;. 25 kg/m2 ≤ BMI ≤ 35 kg/m2;. Have not used any anti-diabetes or weight-loss medications (metformin excluded) within the past 3 months;. Have at least 1 transplantable frozen embryo available at the research center;.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: diabetic ketoacidosis or other acute complications of diabetes;; using drugs that affect appetite or nutrient absorption within the past 2 months (metformin excluded);; uncontrolled hyperthyroidism or hypothyroidism, hypertension, systemic autoimmune diseases, etc. that may affect pregnancy and fetal development;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-05-22 with completion listed for 2029-05-30.

It ran at 3 sites in China (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Clinical pregnancy rate of single cycle frozen embryo transfer, Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy, Pregnancy outcome and complications, Birth weight for gestational age, Apgar scores and Other perinatal outcomes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 890 people with pcos.

With 890 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, PCOS research.