PCOS Immune Function Predicts Metformin Efficacy

Tongji University

Status: Enrolling

Conditions: Metformin; Polycystic Ovary Syndrome; Immune Function

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06325956

Immune status and metformin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Metformin therapy

Experimental group

Description:

Metformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment.

Treatment:

Drug: Metformin