PCOS Immune Function Predicts Metformin Efficacy

Last updated: March 21, 2024
Sponsor: Shanghai 10th People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Metformin

Clinical Study ID

NCT06325956
Immune status and metformin
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged 18-45 years
  • Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)

Exclusion

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 systemdiseases;
  • 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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Metformin
Phase:
Study Start date:
March 16, 2024
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Department of Endocrinology, Shanghai Tenth People's Hospital

    Shanghai, 200072
    China

    Active - Recruiting

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