RecruitingPhase 4NCT06742710

Liraglutide Treatment in Obese Infertile PCOS Women


Sponsor

Peking University Third Hospital

Enrollment

890 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Liraglutide, a hypoglycemic drug, can reduce weight and improve insulin resistance while stabilizing blood glucose metabolism without increasing the risk of hypoglycemia, and has been approved by the State Food and Drug Administration of China and the US Food and Drug Administration for the treatment of obesity. Polycystic ovary syndrome (PCOS) is the main cause of female anovulatory infertility, and it is also a high-risk group of obesity. Previous studies have suggested that liraglutide improves glucose metabolism, body weight, and inflammation levels in obese women with PCOS, and improves sex hormone profiles and menstrual cycles, possibly contributing to increased fertility. Therefore, this project intends to test the following hypothesis through a large sample randomized controlled trial in obese and infertile PCOS women who are assisted by in vitro fertilization-frozen embryo transfer (IVF-FET), using liraglutide before transplantation to reduce weight can improve the live birth rate of assisted reproduction.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether liraglutide (a GLP-1 medication also used for weight loss and diabetes) can improve the chances of successful embryo implantation in obese women with polycystic ovary syndrome (PCOS) who are undergoing frozen embryo transfer as part of IVF. **You may be eligible if...** - You are a woman between 20 and 40 years old - You have been diagnosed with PCOS - Your BMI is between 25 and 35 kg/m² - You have at least one frozen embryo available for transfer at the research center - You have not used weight-loss medications (other than metformin) in the past 3 months **You may NOT be eligible if...** - Your blood sugar (HbA1c) is 9% or higher - You have uncontrolled thyroid disease, high blood pressure, or autoimmune conditions - You have serious heart, liver, or kidney disease - You have a history of 3 or more failed embryo implantations or 2 or more miscarriages - You have a personal or family history of medullary thyroid cancer - You are a current smoker, heavy drinker, or drug user - You have participated in another clinical trial in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiraglutide and metformin

Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.

DRUGMetformin

Metformin 1500 mg/day until pregnancy


Locations(3)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Beijing Obstetrics and Gynecology Hospital

Beijing, China

Haidian District Maternal and Child Health Care Hospital

Beijing, China

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NCT06742710


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