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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called semaglutide (a diabetes/weight-loss drug in the GLP-1 class) can improve metabolic health and increase the chances of pregnancy in women with polycystic ovary syndrome (PCOS) who are overweight and struggling with infertility. **You may be eligible if...** - You are between 22 and 40 years old - You have been diagnosed with PCOS - Your BMI is 28 or higher - You have been unable to conceive after at least 1 year of trying without contraception - You want to become pregnant - Your partner does not have severe fertility issues **You may NOT be eligible if...** - You have a personal or family history of medullary thyroid cancer or a condition called MEN (multiple endocrine neoplasia) - You have a history of pancreatitis - You have Type 1 diabetes or certain other types of diabetes - You have a history of cancer - You have serious heart, liver, kidney, or mental health conditions - You have used metformin or GLP-1 medications in the past 90 days - You have severe endometriosis or a very low egg reserve Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

PekingUFH

Beijing, Beijing Municipality, China

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NCT05702905


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