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