NCT06742710RecruitingPhase 4
Liraglutide Treatment in Obese Infertile PCOS Women
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 890 (estimated)
- First submitted
- 4 Aug 2024
- Start date
- 22 May 2025
- Primary completion date
- 30 May 2029
- Lead sponsor
- Peking University Third Hospital
- Diseases
- Obesity
- NCT number
- NCT06742710
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 890
- From 22 May 2025 to the primary completion date, 30 May 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Using drugs that affect appetite or nutrient absorption within the past 2 months (metformin excluded);
- 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;
- 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.);
- 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;
Other illness
- Diabetic ketoacidosis or other acute complications of diabetes;
- Uncontrolled hyperthyroidism or hypothyroidism, hypertension, systemic autoimmune diseases, etc. that may affect pregnancy and fetal development;
- 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;
- Uncontrolled metabolic, autoimmune, or hereditary disease in the husband;
- Failure to comply with the contraceptive requirements of the study design;
- Failure to take medication regularly and follow up;
- Individuals with other conditions deemed unsuitable for participation in this clinical trial by the investigator;
Lab values
- HbA1c ≥ 9.0% before enrollment;
Other
- 17 hydroxyprogesterone in follicualr phase \> 2.0 ng/ml;
Who the study is looking for
- 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.
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Haidian District Maternal and Child Health Care Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.