Immune Function, Metformin, Polycystic Ovary Syndrom
Conditions
Brief summary
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.
Detailed description
PCOS patients and healthy women were recruited in outpatient clinics of three hospitals, and peripheral blood was retained for flow cytometry after completing relevant examinations. In this study, flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescence-labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Interventions
DIAGNOSTIC_TESTDetect the immune function of peripheral blood samples
Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients.
Sponsors
Shanghai 10th People's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. | Samples to be collected once per participant within 7 days of enrollment. | Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. |
| The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. | Samples to be collected once per participant within 7 days of enrollment. | Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| menstrual frequency | Within 7 days of enrollment. | number of menstruation in a year |
| fasting glucose | Within 7 days of enrollment. | fasting glucose (mmol/L) |
| fasting insulin | Within 7 days of enrollment. | fasting insulin (mmol/L) |
| Total cholesterol | Within 7 days of enrollment. | Total cholesterol (mmol/L) |
| Triglycerides | Within 7 days of enrollment. | Triglycerides (mmol/L) |
| HDL-c | Within 7 days of enrollment. | HDL-c (mmol/L) |
| Homeostasis model assessment of insulin resistance | Within 7 days of enrollment. | insulin resistance index |
| total testosterone | Within 7 days of enrollment. | total testosterone (nmol/L) |
| free testosterone | Within 7 days of enrollment. | free testosterone (nmol/L) |
| Sex hormone-binding globulin | Within 7 days of enrollment. | Sex hormone-binding globulin (nmol/L) |
| Androstenedione | Within 7 days of enrollment. | Androstenedione (ng/ml) |
| Dehydroepiandrosterone | Within 7 days of enrollment. | Dehydroepiandrosterone (ug/dl) |
| LDL-c | Within 7 days of enrollment. | LDL-c (mmol/L) |
| body mass index | Within 7 days of enrollment. | body mass index (kg/m2) |
Countries
China
Outcome results
None listed