Polycystic Ovary Syndrome Clinical Trial
Official title:
Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome
In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - aged 18-45 years - Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003) Exclusion Criteria: - Pregnant women; - Hyperthyroidism or hypothyroidism - Severe liver and kidney function injury - Cancer patients; - Associated with severe infection, severe anemia, neutropenia and other blood system diseases; - Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes; - Patients with mental illness or intellectual disability; - Have taken drugs for PCOS treatment in the last three months; - Have a long history of taking hormone therapy; - Currently or recently participating in another clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Department of Endocrinology, Shanghai Tenth People's Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai 10th People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. | Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. | Samples to be collected once per participant within 7 days of enrollment. | |
Primary | The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. | Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. | Samples to be collected once per participant within 7 days of enrollment. | |
Secondary | Homeostasis model assessment of insulin resistance | insulin resistance index | Within 7 days of enrollment. | |
Secondary | body mass index | body mass index (kg/m2) | Within 7 days of enrollment. | |
Secondary | menstrual frequency | number of menstruation in a year | Within 7 days of enrollment. | |
Secondary | fasting glucose | fasting glucose (mmol/L) | Within 7 days of enrollment. | |
Secondary | fasting insulin | fasting insulin (mmol/L) | Within 7 days of enrollment. | |
Secondary | Total cholesterol | Total cholesterol (mmol/L) | Within 7 days of enrollment. | |
Secondary | Triglycerides | Triglycerides (mmol/L) | Within 7 days of enrollment. | |
Secondary | HDL-c | HDL-c (mmol/L) | Within 7 days of enrollment. | |
Secondary | LDL-c | LDL-c (mmol/L) | Within 7 days of enrollment. | |
Secondary | total testosterone | total testosterone (nmol/L) | Within 7 days of enrollment. | |
Secondary | free testosterone | free testosterone (nmol/L) | Within 7 days of enrollment. | |
Secondary | Sex hormone-binding globulin | Sex hormone-binding globulin (nmol/L) | Within 7 days of enrollment. | |
Secondary | Androstenedione | Androstenedione (ng/ml) | Within 7 days of enrollment. | |
Secondary | Dehydroepiandrosterone | Dehydroepiandrosterone (ug/dl) | Within 7 days of enrollment. |
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