Investigating immune function in women with PCOS

Evaluation of Immune Status in Patients with Polycystic Ovary Syndrome

This study is testing how the immune system works in women with Polycystic Ovary Syndrome (PCOS) compared to healthy women to better understand the condition.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Shanghai 10th People's Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06325969 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the immune function characteristics of women diagnosed with Polycystic Ovary Syndrome (PCOS) compared to healthy women. Participants will be recruited from outpatient clinics at three hospitals, and their peripheral blood samples will be analyzed using flow cytometry to detect immune responses. The study seeks to establish an evaluation method for immune function in PCOS patients, which may enhance understanding of the condition's underlying mechanisms.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-45 who meet the Rotterdam criteria for PCOS.

Not a fit: Patients with ovulation disorders due to other endocrine conditions or severe liver and kidney dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for women with PCOS.

How similar studies have performed: While studies on immune function in PCOS are limited, similar approaches have shown promise in understanding other autoimmune and endocrine disorders.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Department of Endocrinology, Shanghai Tenth People's Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Manna Zhang, doctor — Shanghai 10th People's Hospital
• Study coordinator: Manna Zhang, doctor

Conditions Polycystic Ovary Syndrom; Metformin; Immune Function