Clinical trial NCT06325969: PCOS Patients' Immune Alterations
Official title: Evaluation of Immune Status in Patients with Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrom
Metformin
Immune Function
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women older than 18 years or younger than 45 years.

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.

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.

Primary outcomes:
measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
Secondary outcomes:
measure: Homeostasis model assessment of insulin resistance
timeFrame: Within 7 days of enrollment.
measure: body mass index
timeFrame: Within 7 days of enrollment.
measure: menstrual frequency
timeFrame: Within 7 days of enrollment.
measure: fasting glucose
timeFrame: Within 7 days of enrollment.
measure: fasting insulin
timeFrame: Within 7 days of enrollment.
measure: Total cholesterol
timeFrame: Within 7 days of enrollment.
measure: Triglycerides
timeFrame: Within 7 days of enrollment.
measure: HDL-c
timeFrame: Within 7 days of enrollment.
measure: LDL-c
timeFrame: Within 7 days of enrollment.
measure: total testosterone
timeFrame: Within 7 days of enrollment.
measure: free testosterone
timeFrame: Within 7 days of enrollment.
measure: Sex hormone-binding globulin
timeFrame: Within 7 days of enrollment.
measure: Androstenedione
timeFrame: Within 7 days of enrollment.
measure: Dehydroepiandrosterone
timeFrame: Within 7 days of enrollment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Manna Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References: