NCT06775093

Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity

Effects of GLP-1 Receptor Agonists Combined with Metformin and Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Women with PCOS and Obesity

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 392 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

Detailed description

Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.

Conditions

• Polycystic Ovary Syndrome
• Obesity
• Infertility, Female

Interventions

Type	Name	Description
DRUG	GLP-1 receptor agonist	3 months
DRUG	Metformin	3 months
BEHAVIORAL	healthy lifestyle education	3 months

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-01-14
• Last updated: 2025-01-14

Locations

1 site across 1 country: China