Effect of Metformin on Patients With Polycystic Ovary Syndrome

NCT ID: NCT05802212

Last Updated: 2025-11-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-05-01

Brief Summary

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The purpose of the study is to understand the effect of Metformin on patients with PCOS.

Detailed Description

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This study aims to evaluate the effects of Metformin on reproductive endocrine and reproductive outcomes in women with PCOS, and to explore its underlying mechanisms to provide the intervention strategies for PCOS.

Conditions

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PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Volunteers with polycystic ovary syndrome without insulin resistance and intervened with metformin for 12 weeks
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metformin intervention for 12 weeks

Metformin intervention for 12 weeks

Group Type EXPERIMENTAL

Metformin intervention for 12 weeks

Intervention Type DRUG

PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.

Interventions

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Metformin intervention for 12 weeks

PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.

Intervention Type DRUG

Other Intervention Names

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PCOS patients were treated with metformin for 12 weeks

Eligibility Criteria

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Inclusion Criteria

1. Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
2. Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
3. Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention.
4. Volunteers with polycystic ovary syndrome without insulin resistance.

Exclusion Criteria

1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
2. Individuals who are during pregnant, lactation or menopause.
3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
4. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
8. A medical history of severe cardiovascular and cerebrovascular diseases.
9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
10. Individuals who drink more than 15g of alcohol per day or have a smoking habit.
11. Individuals who need drug treatment for any mental illness such as epilepsy and depression.
12. Cancer patients.
13. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
Minimum Eligible Age

20 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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Responsibility Role SPONSOR

Principal Investigators

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Qiaojie, Professor

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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82288102

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

M2021385

Identifier Type: -

Identifier Source: org_study_id

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