Clinical trial
Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
Name
M2021385
Description
The purpose of the study is to understand the effect of Metformin on patients with PCOS.
Trial arms
Trial start
2021-06-01
Estimated PCD
2022-06-01
Trial end
2023-02-01
Status
Completed
Treatment
Metformin intervention for 12 weeks
PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.
Arms:
Metformin intervention for 12 weeks
Other names:
PCOS patients were treated with metformin for 12 weeks
Size
95
Primary endpoint
The species and genus abundance changes of fungi and bacteria gut microbiota composition
before and after 2, 12 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
before intervention
The alterations of secondary metabolites of gut fungi and bacteria
after 2 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
after 12 weeks of intervention
Blood sugar level
before and after 2, 12 weeks of intervention
Fasting insulin
before and after 2, 12 weeks of intervention
Prolactin in serum
before and after 2, 12 weeks of intervention
Follicular stimulating hormone in serum
before and after 2, 12 weeks of intervention
Luteinizing hormone in serum
before and after 2, 12 weeks of intervention
Estradiol in serum
before and after 2, 12 weeks of intervention
Testosterone in serum
before and after 2, 12 weeks of intervention
4-Androstenedione in serum
before and after 2, 12 weeks of intervention
The alterations of plasma lipid metabolites
before intervention
The alterations of plasma lipid metabolites
after 2 weeks of intervention
The alterations of plasma lipid metabolites
after 12 weeks of intervention
Ovarian volume
before intervention
Ovarian volume
after 12 weeks of intervention
Follicle number
before intervention
Follicle number
after 12 weeks of intervention
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Metformin intervention for 12 weeks', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 95, 'type': 'ACTUAL'}}
Updated at
2023-04-06
1 organization
1 product
1 indication
Organization
Peking University Third HospitalProduct
Metformin