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Completed

NCT Number: NCT06325969

PCOS Patients' Immune Alterations

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.

    Time frame: 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.

  2. The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.

    Time frame: 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 outcomes

  1. Homeostasis model assessment of insulin resistance

    Time frame: Within 7 days of enrollment.

    insulin resistance index

  2. body mass index

    Time frame: Within 7 days of enrollment.

    body mass index (kg/m2)

  3. menstrual frequency

    Time frame: Within 7 days of enrollment.

    number of menstruation in a year

  4. fasting glucose

    Time frame: Within 7 days of enrollment.

    fasting glucose (mmol/L)

  5. fasting insulin

    Time frame: Within 7 days of enrollment.

    fasting insulin (mmol/L)

  6. Total cholesterol

    Time frame: Within 7 days of enrollment.

    Total cholesterol (mmol/L)

  7. Triglycerides

    Time frame: Within 7 days of enrollment.

    Triglycerides (mmol/L)

  8. HDL-c

    Time frame: Within 7 days of enrollment.

    HDL-c (mmol/L)

  9. LDL-c

    Time frame: Within 7 days of enrollment.

    LDL-c (mmol/L)

  10. total testosterone

    Time frame: Within 7 days of enrollment.

    total testosterone (nmol/L)

  11. free testosterone

    Time frame: Within 7 days of enrollment.

    free testosterone (nmol/L)

  12. Sex hormone-binding globulin

    Time frame: Within 7 days of enrollment.

    Sex hormone-binding globulin (nmol/L)

  13. Androstenedione

    Time frame: Within 7 days of enrollment.

    Androstenedione (ng/ml)

  14. Dehydroepiandrosterone

    Time frame: Within 7 days of enrollment.

    Dehydroepiandrosterone (ug/dl)

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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