PCOS Immune Function Predicts Metformin Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-16

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome Metformin Immune Function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin therapy

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Take metformin for six months.

Interventions

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Metformin

Take metformin for six months.

Intervention Type DRUG

Other Intervention Names

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Metformin therapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No