Using liraglutide to improve fertility in obese women with PCOS

Liraglutide Treatment in Obese Infertile PCOS Women

This study is testing if giving liraglutide, along with metformin, can help obese women with PCOS improve their chances of having a baby through IVF by losing weight and getting healthier.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 890 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Peking University Third Hospital (other)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06742710 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 20-40 with a BMI between 25 and 35 who have been diagnosed with PCOS and have at least one transplantable frozen embryo.

Not a fit: Patients with uncontrolled diabetes, significant cardiovascular or systemic diseases, or those who have used certain medications affecting appetite or absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve fertility outcomes for obese women with PCOS.

How similar studies have performed: Previous studies have indicated that liraglutide may improve metabolic parameters in similar populations, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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

Conditions: PCOS, Obesity, Infertility, polycystic ovary syndrome, liraglutide, infertile, obesity