Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome

Phase

Condition

Holoprosencephaly

Birth Defects

Polycystic Ovarian Syndrome

Treatment

Semaglutide, 1.34 mg/mL

Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG

physical exercise

Clinical Study ID

NCT05702905

2022CR04

Ages 22-40
Female

Study 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.

Eligibility Criteria

Inclusion

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 contraceptionfor more than 1 year
Willing to be pregnant, and her husband has no serious infertility

Exclusion

Exclusion Criteria:

History of acute pancreatitis, individual or family history of medullary thyroidcancer and multiple endocrine adenomas
Type 1 diabetes and special type diabetes
History of tumor
Serious cardiovascular and cerebrovascular disease, mental disease, liver or kidneydisease
Metformin, GLP-1 RA and other drugs affecting reproductive and metabolic functionswere used within 90 days before the study
Known allergy to metformin, GLP-1 RA and excipients
Severe endometriosis, low ovarian reserve, premature ovarian failure
Inability to tolerate pregnancy and ovulation induction therapy
Other conditions considered unsuitable for this study by researchers

Study Design

Semaglutide, 1.34 mg/mL

May 09, 2023

June 30, 2025

Study Description

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. Metformin and semaglutide will be administered in a dose increasing mode, and then maintain until the end of 12 weeks, and metabolic related indexes will be evaluated. After 12 weeks of treatment, all subjects will 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 to evaluate the fertility related indicators. 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.

Connect with a study center

PekingUFH
Peking, Beijing 100034
China
Active - Recruiting

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