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Liraglutide Treatment in Obese Infertile PCOS Women

Study acronym: LITOP
StatusRecruiting
PhasePhase 4
Started2025-05-22
View on ClinicalTrials.gov ↗

Amendment history

2025-05-22
notable
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-06-30→2029-05-30
Completion date2028-06-30→2029-12-31
Start dateestimated 2025-02-10→confirmed 2025-05-22
Study sites0→3
2025-01-19
minor
Study Status, Outcome Measures v1
Start date2025-01-01→2025-02-10
Secondary endpoints6 to 8 entries
Accumulated live birth rate Accumulated clinical pregnancy rate
2024-12-18
minor
Original filing
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.
Trial Details
NCT Number NCT06742710
Lead Sponsor Peking University Third Hospital
Conditions PCOS, Obesity, Infertility
Enrollment 890 participants
Start Date 2025-05-22
Primary Completion 2029-05-30 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-29