PCOS Patients' Immune Alterations

NCT ID: NCT06325969

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2025-07-10

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.

Conditions

Polycystic Ovary Syndrom; Metformin; Immune Function

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with PCOS

Women aged 18 to 45 who meet the 2003 Rotterdam criteria for PCOS.

Detect the immune function of peripheral blood samples

Intervention Type: DIAGNOSTIC_TEST

Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients.

Women without PCOS

Non-PCOS women aged 18 to 45.

Detect the immune function of peripheral blood samples

Intervention Type: DIAGNOSTIC_TEST

Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients.

Interventions

Detect the immune function of peripheral blood samples

Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Manna

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manna Zhang, doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

PCOS Immune

Identifier Type: -

Identifier Source: org_study_id