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Completed

NCT Number: NCT05802212

Effect of Metformin on Patients With Polycystic Ovary Syndrome

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

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Metformin intervention for 12 weeks

Drug

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

Other names: PCOS patients were treated with metformin for 12 weeks

Primary outcomes

  1. Luteinizing hormone in serum

    Time frame: before and after 2, 12 weeks of intervention

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

  2. 4-Androstenedione in serum

    Time frame: before and after 2, 12 weeks of intervention

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

Secondary outcomes

  1. Testosterone in serum

    Time frame: before and after 2, 12 weeks of intervention

    Changes of testosterone(nmol/L) in serum after the intervention.

  2. Estradiol in serum

    Time frame: before and after 2, 12 weeks of intervention

    Changes of estradiol(pmol/L) in serum after the intervention.

  3. Prolactin in serum

    Time frame: before and after 2, 12 weeks of intervention

    Changes of prolactin(ng/mL) in serum after the intervention.

  4. Follicle number

    Time frame: after 12 weeks of intervention

    The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.

  5. Follicle number

    Time frame: before intervention

    The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.

  6. Ovarian volume

    Time frame: after 12 weeks of intervention

    The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.

  7. Ovarian volume

    Time frame: before intervention

    The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.

  8. The alterations of plasma lipid metabolites

    Time frame: after 12 weeks of intervention

    Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.

  9. The alterations of plasma lipid metabolites

    Time frame: after 2 weeks of intervention

    Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.

  10. The alterations of plasma lipid metabolites

    Time frame: before intervention

    Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.

  11. Fasting insulin

    Time frame: before and after 2, 12 weeks of intervention

    Changes in plasma insulin concentration after the intervention.

  12. Blood sugar level

    Time frame: before and after 2, 12 weeks of intervention

    Changes in plasma glucose concentration after the intervention.

  13. The alterations of secondary metabolites of gut fungi and bacteria

    Time frame: after 12 weeks of intervention

    Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics

  14. The alterations of secondary metabolites of gut fungi and bacteria

    Time frame: after 2 weeks of intervention

    Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics

  15. The alterations of secondary metabolites of gut fungi and bacteria

    Time frame: before intervention

    Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics

  16. The species and genus abundance changes of fungi and bacteria gut microbiota composition

    Time frame: before and after 2, 12 weeks of intervention

    Determination the species and genus abundance changes of gut microbiota among before and after intervention by ITS genomic

  17. Follicular stimulating hormone in serum

    Time frame: before and after 2, 12 weeks of intervention

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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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