RecruitingPhase 4NCT05702905

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

Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study

Sponsor

Peking University First Hospital

Enrollment

75 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

PCOS (Polycystic Ovary Syndrome)Semaglutide

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

Sex: FEMALEMin Age: 22 YearsMax Age: 40 Years

Inclusion Criteria5

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 Criteria9

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
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

Interventions

DRUGMetformin Hydrochloride 500 MG

Metformin oral tablet (500mg per tablet) will be administered in a dose increasing mode: the initial dose will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks.

DRUGSemaglutide, 1.34 mg/mL

Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and increased to 1.0mg QW after another 4 weeks, and then maintained 1.0mg until the end of treatment in total 12 weeks.

DRUGSemaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG

Both Semaglutide injection and Metformin oral tablet will be administered as described above.

BEHAVIORALcalorie-restricted diet

All subjects after randomization will be reviewed and evaluated by a nutritionist, and then will receive diet guidance. The clinical nutritionist will develop a written nutrition plan for each subject. The nutrition plan of this study adopted the method of calorie restriction diet (CRD) to develop a diet, which required 83.68 kJ/kg of energy per day, 1.2 g/kg of protein per day, 40%\~55% of carbohydrate energy supply ratio, and 20%\~30% of fat energy supply ratio, to ensure the intake of vegetables, fruits and other rich dietary fiber, and drinking more than 1.5 L per day. The nutritionist will explain the method of food exchange in detail to enrich the food types of patients. The diet diary will be distributed to each subject, and the subjects will be required to make a return visit once every four weeks, return the diet diary each time, and receive guidance according to their compliance.

BEHAVIORALphysical exercise

All subjects after randomization will be reviewed and evaluated by a trainer, and then will receive guidance of physical exercise.The trainer will formulate an exercise plan for each subject. The exercise plan consists of 30 minutes of moderate and low intensity continuous aerobic exercise every day, with a frequency of 5-7 days/week. The form of exercise can be determined according to personal hobbies, such as fast walking, jogging, climbing, swimming, etc. The exercise diary will be distributed to each subject, and the subjects are required to make a return visit once every four weeks, return the exercise diary each time, and the trainer will provide guidance to the subjects according to their compliance.