PCOS Immune Function Predicts Metformin Efficacy

Polycystic Ovary Syndrome Clinical Trial

Official title:

Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325956
• Other study ID #: Immune status and metformin
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: March 2024
• Source: Shanghai 10th People's Hospital
• Contact: Manna Zhang, doctor
• Phone: +8613774448495
• Email: mannazhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Function
• Metformin
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Take metformin for six months.

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.	Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.	Samples to be collected once per participant within 7 days of enrollment.
Primary	The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.	Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	Homeostasis model assessment of insulin resistance	insulin resistance index	Within 7 days of enrollment.
Secondary	body mass index	body mass index (kg/m2)	Within 7 days of enrollment.
Secondary	menstrual frequency	number of menstruation in a year	Within 7 days of enrollment.
Secondary	fasting glucose	fasting glucose (mmol/L)	Within 7 days of enrollment.
Secondary	fasting insulin	fasting insulin (mmol/L)	Within 7 days of enrollment.
Secondary	Total cholesterol	Total cholesterol (mmol/L)	Within 7 days of enrollment.
Secondary	Triglycerides	Triglycerides (mmol/L)	Within 7 days of enrollment.
Secondary	HDL-c	HDL-c (mmol/L)	Within 7 days of enrollment.
Secondary	LDL-c	LDL-c (mmol/L)	Within 7 days of enrollment.
Secondary	total testosterone	total testosterone (nmol/L)	Within 7 days of enrollment.
Secondary	free testosterone	free testosterone (nmol/L)	Within 7 days of enrollment.
Secondary	Sex hormone-binding globulin	Sex hormone-binding globulin (nmol/L)	Within 7 days of enrollment.
Secondary	Androstenedione	Androstenedione (ng/ml)	Within 7 days of enrollment.
Secondary	Dehydroepiandrosterone	Dehydroepiandrosterone (ug/dl)	Within 7 days of enrollment.