Effect of Metformin on Patients With Polycystic Ovary Syndrome

Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome

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

Study Overview

• Status: Completed
• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Intervention / Treatment: Drug: Metformin intervention for 12 weeks

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin intervention for 12 weeks	Drug: Metformin intervention for 12 weeks; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before and after 2, 12 weeks of intervention
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	before intervention
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	after 2 weeks of intervention
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	after 12 weeks of intervention
Blood sugar level	Changes in plasma glucose concentration after the intervention.	before and after 2, 12 weeks of intervention
Fasting insulin	Changes in plasma insulin concentration after the intervention.	before and after 2, 12 weeks of intervention
Prolactin in serum	Changes of prolactin(ng/mL) in serum after the intervention.	before and after 2, 12 weeks of intervention
Follicular stimulating hormone in serum	Changes of follicular stimulating hormone(mIU/mL) in serum after the intervention.	before and after 2, 12 weeks of intervention
Luteinizing hormone in serum	Changes of luteinizing hormone(mIU/mL) in serum after the intervention.	before and after 2, 12 weeks of intervention
Estradiol in serum	Changes of estradiol(pmol/L) in serum after the intervention.	before and after 2, 12 weeks of intervention
Testosterone in serum	Changes of testosterone(nmol/L) 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
The alterations of plasma lipid metabolites	Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.	before intervention
The alterations of plasma lipid metabolites	Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.	after 2 weeks of intervention
The alterations of plasma lipid metabolites	Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.	after 12 weeks of intervention
Ovarian volume	The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.	before intervention
Ovarian volume	The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.	after 12 weeks of intervention
Follicle number	The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.	before intervention
Follicle number	The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.	after 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Qiaojie, Professor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: M2021385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No