PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Conditions
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.
Interventions
DRUGMetformin intervention for 12 weeks
PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.
Sponsors
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Volunteers with polycystic ovary syndrome without insulin resistance and intervened with metformin for 12 weeks
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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. 4. Volunteers with polycystic ovary syndrome without insulin resistance.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Luteinizing hormone in serum | before and after 2, 12 weeks of intervention | Changes of luteinizing hormone(mIU/mL) 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolactin in serum | before and after 2, 12 weeks of intervention | Changes of prolactin(ng/mL) 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. |
| 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. |
| The alterations of plasma lipid metabolites | after 12 weeks of intervention | Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics. |
| Testosterone in serum | before and after 2, 12 weeks of intervention | Changes of testosterone(nmol/L) in serum after the intervention. |
| Blood sugar level | before and after 2, 12 weeks of intervention | Changes in plasma glucose concentration after the intervention. |
| 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 |
| 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 |
| 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. |
| Fasting insulin | before and after 2, 12 weeks of intervention | Changes in plasma insulin concentration after the intervention. |
| Estradiol in serum | before and after 2, 12 weeks of intervention | Changes of estradiol(pmol/L) in serum after the intervention. |
Countries
China
Outcome results
None listed