PCOS Patients' Immune Alterations

Last updated: December 7, 2024
Sponsor: Shanghai 10th People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

Detect the immune function of peripheral blood samples

Clinical Study ID

NCT06325969
PCOS Immune
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 tomeet the presence of two of three of the following criteria: oligo-anovulation,hyperandrogenism, and polycystic ovaries (≥ 12 follicles measuring 2-9 mm indiameter and/or an ovarian volume > 10 mL in at least one ovary).

Exclusion

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, adrenaltumors, 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 orother secondary diabetes;

  • History of malignant tumor;

  • Severe infection, severe anemia, neutropenia, and other chronic diseases of thesystem;

  • 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, includingthiazolidinedione, metformin, SGLT-2i, acarbose, and glucagon-like peptide-1receptor agonist (GLP-1RA), have been used in the past 3 months;

  • Take letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins,gonadotropin-releasing hormone agonists, antiandrogens (spironolactone, cyproteroneacetate, 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

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Detect the immune function of peripheral blood samples
Phase:
Study Start date:
March 16, 2024
Estimated Completion Date:
March 08, 2026

Study 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.

Connect with a study center

  • Department of Endocrinology, Shanghai Tenth People's Hospital

    Shanghai, 200072
    China

    Active - Recruiting

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