Clinical trial NCT05802212: Effect of Metformin on Patients With Polycystic Ovary Syndrome
Official title: Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Metformin intervention for 12 weeks
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: The species and genus abundance changes of fungi and bacteria gut microbiota composition
timeFrame: before and after 2, 12 weeks of intervention
measure: The alterations of secondary metabolites of gut fungi and bacteria
timeFrame: before intervention
measure: The alterations of secondary metabolites of gut fungi and bacteria
timeFrame: after 2 weeks of intervention
measure: The alterations of secondary metabolites of gut fungi and bacteria
timeFrame: after 12 weeks of intervention
measure: Blood sugar level
timeFrame: before and after 2, 12 weeks of intervention
measure: Fasting insulin
timeFrame: before and after 2, 12 weeks of intervention
measure: Prolactin in serum
timeFrame: before and after 2, 12 weeks of intervention
measure: Follicular stimulating hormone in serum
timeFrame: before and after 2, 12 weeks of intervention
measure: Luteinizing hormone in serum
timeFrame: before and after 2, 12 weeks of intervention
measure: Estradiol in serum
timeFrame: before and after 2, 12 weeks of intervention
measure: Testosterone in serum
timeFrame: before and after 2, 12 weeks of intervention
measure: 4-Androstenedione in serum
timeFrame: before and after 2, 12 weeks of intervention
measure: The alterations of plasma lipid metabolites
timeFrame: before intervention
measure: The alterations of plasma lipid metabolites
timeFrame: after 2 weeks of intervention
measure: The alterations of plasma lipid metabolites
timeFrame: after 12 weeks of intervention
measure: Ovarian volume
timeFrame: before intervention
measure: Ovarian volume
timeFrame: after 12 weeks of intervention
measure: Follicle number
timeFrame: before intervention
measure: Follicle number
timeFrame: after 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Qiaojie, Professor
role: STUDY_DIRECTOR
References: