Using liraglutide to improve fertility in obese women with PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of liraglutide, a medication known for its weight loss and insulin resistance benefits, on obese women suffering from polycystic ovary syndrome (PCOS) who are infertile. The study aims to determine if administering liraglutide prior to in vitro fertilization-frozen embryo transfer (IVF-FET) can enhance live birth rates by reducing weight and improving metabolic health. Participants will be randomized to receive either liraglutide combined with metformin or metformin alone, with a focus on evaluating fertility outcomes. The trial will include a large sample size to ensure robust results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;
* Able to follow the study's contraceptive requirements.

Exclusion Criteria:

* Diabetic ketoacidosis or other acute complications of diabetes;
* HbA1c ≥ 9.0% before enrollment;
* 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;
* 17 hydroxyprogesterone in follicualr phase \> 2.0 ng/ml;
* Serious cardiovascular, digestive, liver, or kidney diseases, HBsAg-positive chronic hepatitis B, active pulmonary tuberculosis, or AIDS, etc. that are infectious or hereditary diseases;
* Any psychiatric or psychological disorders requiring drug treatment;
* Poor pregnancy and delivery history: recurrent failed implantations ≥3 times, spontaneous abortions ≥2 times; history of stillbirth, dystocia, or birth defects; previous pregnancies with preeclampsia, eclampsia, or HELLP syndrome;
* Uncontrolled metabolic, autoimmune, or hereditary disease in the husband;
* A contraindication or relative contraindication to using GLP-1 receptor agonists (history of medullary thyroid carcinoma or family history of medullary thyroid carcinoma, acute cholecystitis or pancreatitis in the acute phase or history of previous attacks, GLP-1 receptor agonist allergy, etc.);
* Failure to comply with the contraceptive requirements of the study design;
* Failure to take medication regularly and follow up;
* Current smokers, drug addicts, alcoholics, or individuals with substance abuse;
* Participants who have participated in any clinical trial within the past 3 months prior to screening;
* Individuals with other conditions deemed unsuitable for participation in this clinical trial by the investigator;

Where it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Obstetrics and Gynecology Hospital
  Beijing, China Not yet recruiting
• Haidian District Maternal and Child Health Care Hospital
  Beijing, China Not yet recruiting

Study contacts

• Study coordinator: Haining Wang, Professor
• Email: hainingmail@bjmu.edu.cn
• Phone: 8601082265025

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.