Liraglutide Treatment in Obese Infertile PCOS Women

Sponsor
Peking University Third Hospital
Study ID
NCT06742710
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 22, 2025
Status verified
Dec 2024
Primary completion
May 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
890 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    Liraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day
  • Active Comparator: Control Group
    Metformin 1500 mg/day

Primary Outcome Measure

Live birth rate associated with single cycle frozen embryo transfer [ Time Frame: At delivery ]

Central Contacts

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