Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity
NCT ID: NCT06775093
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
392 participants
INTERVENTIONAL
2025-03-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GLP-1 RAs combined with metformin and healthy lifestyle education
Benaglutide injection (Fisuomei®, National Medicine Standard No. S20230042, Shanghai Renhui Biopharmaceutical Co., Ltd.) was administered at an initial dose of 0.06 mg per injection, three times daily, via subcutaneous injection 5 minutes before meals. After establishing tolerance, the dose was increased weekly by 0.04 mg per injection, reaching 0.2 mg per injection after four weeks, administered three times daily for a total of 12 weeks. Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was prescribed at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medications were discontinued. Patients were advised to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatments were initiated 4 weeks after completing the weight loss phase.
GLP-1 receptor agonist
3 months
Metformin
3 months
healthy lifestyle education
3 months
metformin and healthy lifestyle education
Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was administered at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medication was discontinued. Patients were instructed to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatment was initiated 4 weeks after completing the weight loss phase.
Metformin
3 months
healthy lifestyle education
3 months
Interventions
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GLP-1 receptor agonist
3 months
Metformin
3 months
healthy lifestyle education
3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Jie Qiao
Dean
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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M2024472
Identifier Type: -
Identifier Source: org_study_id
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