Liraglutide Treatment in Obese Infertile PCOS Women

NCT06742710 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 890

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Liraglutide and metformin

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

DRUG

Metformin

Metformin 1500 mg/day until pregnancy

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2029-05-30
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06742710 on ClinicalTrials.gov