Liraglutide Treatment in Obese Infertile PCOS Women

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Obstetrics and Gynecology Hospital
NOT_YET_RECRUITING
Beijing
Haidian District Maternal and Child Health Care Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Contact Information
Primary
Haining Wang, Professor
hainingmail@bjmu.edu.cn
8601082265025
Backup
Ye Liu, Associate Professor
yeliumed@bjmu.edu.cn
8601082265025
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 890
Treatments
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
Sponsors
Leads: Peking University Third Hospital

This content was sourced from clinicaltrials.gov