EICHORCondition: Polycystic Ovary Syndrom · Metformin · Immune Function · Sponsor: Shanghai 10th People's Hospital
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Department of Endocrinology, Shanghai Tenth People's Hospital | Shanghai, China | — |
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Source record: clinicaltrials.gov/study/NCT06325969