Effect of Metformin on Patients With Polycystic Ovary Syndrome

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

Detailed Description
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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.

Official Title
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Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome

Conditions
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PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Intervention / Treatment
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* Drug: Metformin intervention for 12 weeks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Metformin intervention for 12 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin intervention for 12 weeks<br>Metformin intervention for 12 weeks | Drug: Metformin intervention for 12 weeks<br>* PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.<br>* Other names: PCOS patients were treated with metformin for 12 weeks;|

What is the study measuring?
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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 |