Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity

NCT ID: NCT06775093

Last Updated: 2025-01-14

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-12-31

Brief Summary

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The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

Detailed Description

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Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.

Conditions

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Polycystic Ovary Syndrome Obesity Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

GLP-1 receptor agonist

Intervention Type DRUG

3 months

Metformin

Intervention Type DRUG

3 months

healthy lifestyle education

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

3 months

healthy lifestyle education

Intervention Type BEHAVIORAL

3 months

Interventions

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GLP-1 receptor agonist

3 months

Intervention Type DRUG

Metformin

3 months

Intervention Type DRUG

healthy lifestyle education

3 months

Intervention Type BEHAVIORAL

Other Intervention Names

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Benaglutide

Eligibility Criteria

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Inclusion Criteria

Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI\<35kg/m2;

Exclusion Criteria

Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (\>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jie Qiao

Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Shuo Huang

Role: CONTACT

+861082266699

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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