PCOS Patients' Immune Alterations

NCT06325969 | Completed DMC

• 1 other identifier: PCOS Immune
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrom; Metformin; Immune Function

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (14)

• Homeostasis model assessment of insulin resistance

  Within 7 days of enrollment.

• body mass index

  Within 7 days of enrollment.

• menstrual frequency

  Within 7 days of enrollment.

• fasting glucose

  Within 7 days of enrollment.

• fasting insulin

  Within 7 days of enrollment.

Study Arms (2)

Women with PCOS

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

Diagnostic Test: Detect the immune function of peripheral blood samples

Women without PCOS

Non-PCOS women aged 18 to 45.

Diagnostic Test: Detect the immune function of peripheral blood samples

Interventions

Detect the immune function of peripheral blood samples DIAGNOSTIC_TEST

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

Women with PCOS; Women without PCOS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women older than 18 years or younger than 45 years.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

Study Officials

• Manna Zhang, doctor

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 22, 2024
• Study Start: November 3, 2023
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)