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Trial Title: PCOS Immune Function Predicts Metformin Efficacy

NCT ID: NCT06325956

Condition: Polycystic Ovary Syndrome
Metformin
Immune Function

Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Metformin

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Metformin
Description: Take metformin for six months.
Arm group label: Metformin therapy

Other name: Metformin therapy

Summary: 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.

Detailed description: In this study, peripheral blood samples of PCOS patients were collected before and after intervention. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescently labeled antibodies in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Endocrinology, Shanghai Tenth People's Hospital

Address:
City: Shanghai
Zip: 200072
Country: China

Status: Recruiting

Contact:
Last name: Manna Zhang, Doctor

Phone: 86-21-66301004
Email: mannazhang@126.com

Start date: March 16, 2024

Completion date: July 1, 2026

Lead sponsor:
Agency: Shanghai 10th People's Hospital
Agency class: Other

Source: Shanghai 10th People's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06325956

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