Effect of Metformin on Patients With Polycystic Ovary Syndrome

NCT05802212 | Completed

• 2 other identifiers: M202138582288102
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Outcome Measures

Primary Outcomes (2)

• Luteinizing hormone in serum

  Changes of luteinizing hormone(mIU/mL) in serum after the intervention.

  before and after 2, 12 weeks of intervention

• 4-Androstenedione in serum

  Changes of 4-Androstenedione(pmol/L) in serum after the intervention.

  before and after 2, 12 weeks of intervention

Secondary Outcomes (17)

• Testosterone in serum

  before and after 2, 12 weeks of intervention

• Estradiol in serum

  before and after 2, 12 weeks of intervention

• Prolactin in serum

  before and after 2, 12 weeks of intervention

• Follicle number

  after 12 weeks of intervention

• Follicle number

  before intervention

Study Arms (1)

Metformin intervention for 12 weeks

EXPERIMENTAL

Metformin intervention for 12 weeks

Drug: Metformin intervention for 12 weeks

Interventions

Metformin intervention for 12 weeks DRUG

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

Also known as: PCOS patients were treated with metformin for 12 weeks

Metformin intervention for 12 weeks

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
• 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.

You may not qualify if:

• Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
• Individuals who are during pregnant, lactation or menopause.
• Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
• Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
• Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
• Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
• Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
• A medical history of severe cardiovascular and cerebrovascular diseases.
• 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.
• Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Qiaojie, Professor

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Volunteers with polycystic ovary syndrome without insulin resistance and intervened with metformin for 12 weeks

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: April 6, 2023
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: May 1, 2023
• Last Updated: November 25, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)