Effect of Metformin on Patients With Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Interventions: Drug: Metformin intervention for 12 weeks

• Registration Number: NCT05802212
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-06-01
• Status Verified: 2023-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-03-26
• Last Update Submitted: 2023-03-26
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin intervention for 12 weeks	Metformin intervention for 12 weeks	Metformin intervention for 12 weeks

Primary Outcome Measures

Name	Time	Method
Fasting insulin	before and after 2, 12 weeks of intervention	Changes in plasma insulin concentration after the intervention.
Prolactin in serum	before and after 2, 12 weeks of intervention	Changes of prolactin(ng/mL) in serum after the intervention.
The species and genus abundance changes of fungi and bacteria gut microbiota composition	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
The alterations of secondary metabolites of gut fungi and bacteria	after 12 weeks of intervention	Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Blood sugar level	before and after 2, 12 weeks of intervention	Changes in plasma glucose concentration after the intervention.
Follicular stimulating hormone in serum	before and after 2, 12 weeks of intervention	Changes of follicular stimulating hormone(mIU/mL) in serum after the intervention.
Luteinizing hormone in serum	before and after 2, 12 weeks of intervention	Changes of luteinizing hormone(mIU/mL) in serum after the intervention.
The alterations of plasma lipid metabolites	after 12 weeks of intervention	Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Ovarian volume	after 12 weeks of intervention	The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Estradiol in serum	before and after 2, 12 weeks of intervention	Changes of estradiol(pmol/L) in serum after the intervention.
Testosterone in serum	before and after 2, 12 weeks of intervention	Changes of testosterone(nmol/L) in serum after the intervention.
4-Androstenedione in serum	before and after 2, 12 weeks of intervention	Changes of 4-Androstenedione(pmol/L) in serum after the intervention.
Follicle number	after 12 weeks of intervention	The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China