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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