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CompletedNo phase

PCOS Patients' Immune Alterations

Key facts

Who runs it
Shanghai 10th People's Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
162 people enrolled
Started
3 Nov 2023
Ended
10 Jul 2025
Type of study
Observational, 2 groups
Treatments tested
  • Detect the immune function of peripheral blood samples
Record updated
11 July 2025

Who can take part

Age
18 years to 45 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • 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
  • 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
  • Mental illness, dementia, or other cognitive behavioral problems
  • Female patients younger than 18 years old or older than 45 years old
  • Severe liver and kidney dysfunction (more than 3 times the normal value)
  • Patients undergoing total hysterectomy or ovarian adnexectomy
  • Pregnant or lactating patients
  • Female patients with a BMI less than 20kg/m2

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Women with PCOS

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

    Treatment: Detect the immune function of peripheral blood samples

  • Women without PCOS

    Non-PCOS women aged 18 to 45.

    Treatment: Detect the immune function of peripheral blood samples

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome
Record updated
11 July 2025