NCT06742710 Liraglutide Treatment in Obese Infertile PCOS Women
| NCT ID | NCT06742710 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University Third Hospital |
| Condition | PCOS |
| Study Type | INTERVENTIONAL |
| Enrollment | 890 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2029-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 890 participants in total. It began in 2025-05-22 with a primary completion date of 2029-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06742710 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying PCOS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06742710 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06742710 currently recruiting?
Yes, NCT06742710 is actively recruiting participants. Contact the research team at hainingmail@bjmu.edu.cn for enrollment information.
Where is the NCT06742710 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China.
Who is sponsoring the NCT06742710 clinical trial?
NCT06742710 is sponsored by Peking University Third Hospital. The trial plans to enroll 890 participants.