Completed

Metformin's Impact on Reproductive Outcomes in Polycystic Ovary Syndrome

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Study Aim

This study aims to observe how metformin affects hormone levels related to reproductive health in women with polycystic ovary syndrome.

What is being tested

Metformin intervention for 12 weeks

Drug
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Adnexal Diseases

From 20 to 40 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: June 2020
See protocol details

Summary

Principal SponsorPeking University Third Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2020

Actual date on which the first participant was enrolled.

This study is focused on understanding how the medication Metformin affects women who have Polycystic Ovary Syndrome (PCOS). Researchers are particularly interested in how Metformin influences reproductive hormones and the reproductive health outcomes in these women. PCOS is a common condition that can cause irregular periods, excessive hair growth, and difficulties with fertility. By studying Metformin's effects, the research aims to find better ways to manage these symptoms and improve overall reproductive health for women with PCOS. Participants in the study will be given Metformin, and researchers will monitor changes in specific hormones in their blood. The study looks at how levels of hormones like 4-Androstenedione and luteinizing hormone change in response to the medication. These measurements help determine how Metformin might help balance hormones and improve symptoms associated with PCOS. This research could potentially lead to more effective treatment strategies for women dealing with this condition.

Official TitleEffect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
NCT05802212
Principal SponsorPeking University Third Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

77 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCystsEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersNeoplasmsOvarian CystsOvarian DiseasesPolycystic Ovary SyndromeFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
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).
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.
Volunteers with polycystic ovary syndrome without insulin resistance.
13 exclusion criteria prevent from participating
Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
Individuals who drink more than 15g of alcohol per day or have a smoking habit.
Individuals who need drug treatment for any mental illness such as epilepsy and depression.
Cancer patients.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Metformin intervention for 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Peking University Third Hospital

Beijing, ChinaOpen Peking University Third Hospital in Google Maps
CompletedOne Study Center