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Effect of Metformin on Patients With Polycystic Ovary Syndrome

Primary Purpose

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metformin intervention for 12 weeks
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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. 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.

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin intervention for 12 weeks

Arm Description

Metformin intervention for 12 weeks

Outcomes

Primary Outcome Measures

The species and genus abundance changes of fungi and bacteria gut microbiota composition
Determination the species and genus abundance changes of gut microbiota among before and after intervention by ITS genomic
The alterations of secondary metabolites of gut fungi and bacteria
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
The alterations of secondary metabolites of gut fungi and bacteria
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
The alterations of secondary metabolites of gut fungi and bacteria
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Blood sugar level
Changes in plasma glucose concentration after the intervention.
Fasting insulin
Changes in plasma insulin concentration after the intervention.
Prolactin in serum
Changes of prolactin(ng/mL) in serum after the intervention.
Follicular stimulating hormone in serum
Changes of follicular stimulating hormone(mIU/mL) in serum after the intervention.
Luteinizing hormone in serum
Changes of luteinizing hormone(mIU/mL) in serum after the intervention.
Estradiol in serum
Changes of estradiol(pmol/L) in serum after the intervention.
Testosterone in serum
Changes of testosterone(nmol/L) in serum after the intervention.
4-Androstenedione in serum
Changes of 4-Androstenedione(pmol/L) in serum after the intervention.
The alterations of plasma lipid metabolites
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
The alterations of plasma lipid metabolites
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
The alterations of plasma lipid metabolites
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Ovarian volume
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Ovarian volume
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Follicle number
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Follicle number
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2023
Last Updated
March 26, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05802212
Brief Title
Effect of Metformin on Patients With Polycystic Ovary Syndrome
Official Title
Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to understand the effect of Metformin on patients with PCOS.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Metformin intervention for 12 weeks
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin intervention for 12 weeks
Arm Type
Experimental
Arm Description
Metformin intervention for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin intervention for 12 weeks
Other Intervention Name(s)
PCOS patients were treated with metformin for 12 weeks
Intervention Description
PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.
Primary Outcome Measure Information:
Title
The species and genus abundance changes of fungi and bacteria gut microbiota composition
Description
Determination the species and genus abundance changes of gut microbiota among before and after intervention by ITS genomic
Time Frame
before and after 2, 12 weeks of intervention
Title
The alterations of secondary metabolites of gut fungi and bacteria
Description
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Time Frame
before intervention
Title
The alterations of secondary metabolites of gut fungi and bacteria
Description
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Time Frame
after 2 weeks of intervention
Title
The alterations of secondary metabolites of gut fungi and bacteria
Description
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Time Frame
after 12 weeks of intervention
Title
Blood sugar level
Description
Changes in plasma glucose concentration after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
Fasting insulin
Description
Changes in plasma insulin concentration after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
Prolactin in serum
Description
Changes of prolactin(ng/mL) in serum after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
Follicular stimulating hormone in serum
Description
Changes of follicular stimulating hormone(mIU/mL) in serum after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
Luteinizing hormone in serum
Description
Changes of luteinizing hormone(mIU/mL) in serum after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
Estradiol in serum
Description
Changes of estradiol(pmol/L) in serum after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
Testosterone in serum
Description
Changes of testosterone(nmol/L) in serum after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
4-Androstenedione in serum
Description
Changes of 4-Androstenedione(pmol/L) in serum after the intervention.
Time Frame
before and after 2, 12 weeks of intervention
Title
The alterations of plasma lipid metabolites
Description
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Time Frame
before intervention
Title
The alterations of plasma lipid metabolites
Description
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Time Frame
after 2 weeks of intervention
Title
The alterations of plasma lipid metabolites
Description
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Time Frame
after 12 weeks of intervention
Title
Ovarian volume
Description
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Time Frame
before intervention
Title
Ovarian volume
Description
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Time Frame
after 12 weeks of intervention
Title
Follicle number
Description
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Time Frame
before intervention
Title
Follicle number
Description
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Time Frame
after 12 weeks of intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiaojie, Professor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Metformin on Patients With Polycystic Ovary Syndrome

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