ClinConnect ClinConnect Logo
Search / Trial NCT06325969

PCOS Patients' Immune Alterations

Launched by SHANGHAI 10TH PEOPLE'S HOSPITAL · Mar 21, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system functions in women with Polycystic Ovary Syndrome (PCOS). Researchers want to understand the unique characteristics of the immune system in these patients compared to healthy women. To do this, they will collect blood samples from participants and analyze them using a special technique called flow cytometry. This study aims to help create a method for evaluating immune function in women with PCOS, which could lead to better understanding and treatment options.

Women between the ages of 18 and 45 who have been diagnosed with PCOS may be eligible to join the study. To qualify, they must meet specific criteria related to their menstrual cycles and hormone levels. Participants will be asked to voluntarily join the study and sign an informed consent form. If you decide to participate, you can expect to provide a blood sample for testing and contribute to important research that could help improve care for women with PCOS in the future.

Gender

FEMALE

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.

About Shanghai 10th People's Hospital

Shanghai 10th People's Hospital, affiliated with Tongji University, is a leading clinical research institution in China known for its commitment to advancing medical science and improving patient care. With a focus on innovative therapies and cutting-edge research methodologies, the hospital conducts a wide range of clinical trials across various medical disciplines. Its state-of-the-art facilities and multidisciplinary team of experts enable rigorous study designs and high-quality data collection, fostering collaboration with both national and international partners. The hospital is dedicated to upholding ethical standards and promoting patient safety, ensuring that its clinical trials contribute significantly to the global medical community.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Manna Zhang, doctor

Principal Investigator

Shanghai 10th People's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported