Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycyst… (NCT05702905) | Clinical Trial Compass
UnknownPhase 4
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome
China75 participantsStarted 2023-05-09
Plain-language summary
To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.
Who can participate
Age range22 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Meet the PCOS diagnostic criteria (Rotterdam）
✓. Age 22-40
✓. BMI ≥ 28 kg/m2
✓. Infertility: having normal sexual life and failing to conceive without contraception for more than 1 year
✓. Willing to be pregnant, and her husband has no serious infertility
Exclusion criteria
✕. History of acute pancreatitis, individual or family history of medullary thyroid cancer and multiple endocrine adenomas
✕. Type 1 diabetes and special type diabetes
✕. History of tumor
✕. Serious cardiovascular and cerebrovascular disease, mental disease, liver or kidney disease
✕. Metformin, GLP-1 RA and other drugs affecting reproductive and metabolic functions were used within 90 days before the study
What they're measuring
1
Percentage change in bodyweight at 12 weeks for semaglutide versus metformin
Timeframe: at the end of 12 weeks of treatment
2
Achievement of weight reduction of at least 5% at 12 weeks for semaglutide versus metformin