Semaglutide improves fertility and metabolic health in obese women with PCOS
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study
This study is testing if a medication called semaglutide can help obese women with PCOS lose weight and improve their chances of getting pregnant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 22 Years to 40 Years |
| Sex | Female |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Peking, Beijing) |
| Trial ID | NCT05702905 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of semaglutide in treating obese infertile women aged 22-40 with polycystic ovary syndrome (PCOS). A total of 75 participants will be randomly assigned to receive either metformin, semaglutide, or a combination of both, alongside a calorie-restricted diet and physical exercise for 12 weeks. The primary focus is on weight loss percentage, while secondary outcomes include metabolic markers, ovulation rates, and pregnancy outcomes over a 24-week follow-up period. The study aims to provide insights into how these treatments can improve fertility and metabolic health in this population.
Who should consider this trial
Good fit: Ideal candidates are obese infertile women aged 22-40 who meet the diagnostic criteria for PCOS.
Not a fit: Patients with severe endometriosis, low ovarian reserve, or those unable to tolerate pregnancy and ovulation induction therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance fertility and metabolic health in obese women suffering from PCOS.
How similar studies have performed: Other studies have shown promise in using similar approaches for managing PCOS and improving fertility outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the PCOS diagnostic criteria (Rotterdam） 2. Age 22-40 3. BMI ≥ 28 kg/m2 4. Infertility: having normal sexual life and failing to conceive without contraception for more than 1 year 5. Willing to be pregnant, and her husband has no serious infertility Exclusion Criteria: 1. History of acute pancreatitis, individual or family history of medullary thyroid cancer and multiple endocrine adenomas 2. Type 1 diabetes and special type diabetes 3. History of tumor 4. Serious cardiovascular and cerebrovascular disease, mental disease, liver or kidney disease 5. Metformin, GLP-1 RA and other drugs affecting reproductive and metabolic functions were used within 90 days before the study 6. Known allergy to metformin, GLP-1 RA and excipients 7. Severe endometriosis, low ovarian reserve, premature ovarian failure 8. Inability to tolerate pregnancy and ovulation induction therapy 9. Other conditions considered unsuitable for this study by researchers
Where this trial is running
Peking, Beijing
- PekingUFH — Peking, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Tingting Zhang, M.D. — Peking University First Hospital
- Study coordinator: Tingting Zhang, M.D.
- Email: cathine@sina.com
- Phone: 86-10-83575103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.