Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
时间窗: 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 number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
时间窗: 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.
次要结局
- Triglycerides(Within 7 days of enrollment.)
- HDL-c(Within 7 days of enrollment.)
- fasting insulin(Within 7 days of enrollment.)
- Total cholesterol(Within 7 days of enrollment.)
- total testosterone(Within 7 days of enrollment.)
- free testosterone(Within 7 days of enrollment.)
- Androstenedione(Within 7 days of enrollment.)
- Homeostasis model assessment of insulin resistance(Within 7 days of enrollment.)
- body mass index(Within 7 days of enrollment.)
- menstrual frequency(Within 7 days of enrollment.)
- fasting glucose(Within 7 days of enrollment.)
- LDL-c(Within 7 days of enrollment.)
- Dehydroepiandrosterone(Within 7 days of enrollment.)
- Sex hormone-binding globulin(Within 7 days of enrollment.)
研究者
Zhang Manna
Prof.
Shanghai 10th People's Hospital