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

PHASE4RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

May 9, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2025

Conditions
PCOS (Polycystic Ovary Syndrome)Semaglutide
Interventions
DRUG

Metformin 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.

DRUG

Semaglutide, 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.

DRUG

Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG

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

BEHAVIORAL

calorie-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.

BEHAVIORAL

physical 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.

Trial Locations (1)

100034

RECRUITING

PekingUFH, Beijing

All Listed Sponsors
lead

Peking University First Hospital

OTHER