PCOS Patients' Immune Alterations

Completed

• Conditions: Immune Function; Polycystic Ovary Syndrom; Metformin

• Registration Number: NCT06325969
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients.

Detailed Description

PCOS patients and healthy women were recruited in outpatient clinics of three hospitals, and peripheral blood was retained for flow cytometry after completing relevant examinations. In this study, flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescence-labeled antibody 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.

Study Timeline

• Study Start: 2023-11-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-22
• Status Verified: 2025-07
• Primary Completion: 2025-07-10
• Study Completion: 2025-07-10
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

• Female subjects aged 18-45 years;
• Voluntarily participate in the experiment, willing to sign the informed consent.
• According to the Rotterdam consensus, polycystic ovarian syndrome (PCOS) needs to meet the presence of two of three of the following criteria: oligo-anovulation, hyperandrogenism, and polycystic ovaries (≥ 12 follicles measuring 2-9 mm in diameter and/or an ovarian volume > 10 mL in at least one ovary).

Exclusion Criteria

• Female patients younger than 18 years old or older than 45 years old;
• Ovulation disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction (hyperthyroidism, hypothyroidism);
• Congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, adrenal tumors, and other diseases causing hyperandrogenemia;
• Severe liver and kidney dysfunction (more than 3 times the normal value)
• Type 1 diabetes, monogenic mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes;
• History of malignant tumor;
• Severe infection, severe anemia, neutropenia, and other chronic diseases of the system;
• Patients undergoing total hysterectomy or ovarian adnexectomy;
• Mental illness, dementia, or other cognitive behavioral problems;
• Hypoglycemic drugs that may affect insulin resistance and androgen levels, including thiazolidinedione, metformin, SGLT-2i, acarbose, and glucagon-like peptide-1 receptor agonist (GLP-1RA), have been used in the past 3 months;
• Take letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, antiandrogens (spironolactone, cyproterone acetate, flutamide, etc.), and other medications for PCOS treatment within the last 3 months.
• Pregnant or lactating patients;
• Female patients with a BMI less than 20kg/m2.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.	Samples to be collected once per participant within 7 days of enrollment.	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.
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.	Samples to be collected once per participant within 7 days of enrollment.	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.

Secondary Outcome Measures

Name	Time	Method
HDL-c	Within 7 days of enrollment.	HDL-c (mmol/L)
fasting insulin	Within 7 days of enrollment.	fasting insulin (mmol/L)
Total cholesterol	Within 7 days of enrollment.	Total cholesterol (mmol/L)
total testosterone	Within 7 days of enrollment.	total testosterone (nmol/L)
free testosterone	Within 7 days of enrollment.	free testosterone (nmol/L)
Androstenedione	Within 7 days of enrollment.	Androstenedione (ng/ml)
Homeostasis model assessment of insulin resistance	Within 7 days of enrollment.	insulin resistance index
body mass index	Within 7 days of enrollment.	body mass index (kg/m2)
menstrual frequency	Within 7 days of enrollment.	number of menstruation in a year
fasting glucose	Within 7 days of enrollment.	fasting glucose (mmol/L)
LDL-c	Within 7 days of enrollment.	LDL-c (mmol/L)
Dehydroepiandrosterone	Within 7 days of enrollment.	Dehydroepiandrosterone (ug/dl)
Sex hormone-binding globulin	Within 7 days of enrollment.	Sex hormone-binding globulin (nmol/L)
Triglycerides	Within 7 days of enrollment.	Triglycerides (mmol/L)

Trial Locations

Locations (1)

Department of Endocrinology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China