PCOS Patients Immune Status Evaluation

Metformin Clinical Trial

Official title:

Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325969
• Other study ID #: PCOS Immune
• Status: Recruiting
• Start date: March 16, 2024
• Est. completion date: March 8, 2026

Study information

• Verified date: March 2024
• Source: Shanghai 10th People's Hospital
• Contact: Manna Zhang, doctor
• Phone: +8613774448495
• Email: mannazhang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 8, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Function
• Metformin
• Polycystic Ovary Syndrom
• Polycystic Ovary Syndrome

Intervention

Diagnostic Test:
• Detect the immune function of peripheral blood samples
Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients.

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.	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.	Samples to be collected once per participant within 7 days of enrollment.
Primary	The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.	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.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	Homeostasis model assessment of insulin resistance	insulin resistance index	Within 7 days of enrollment.
Secondary	body mass index	body mass index (kg/m2)	Within 7 days of enrollment.
Secondary	menstrual frequency	number of menstruation in a year	Within 7 days of enrollment.
Secondary	fasting glucose	fasting glucose (mmol/L)	Within 7 days of enrollment.
Secondary	fasting insulin	fasting insulin (mmol/L)	Within 7 days of enrollment.
Secondary	Total cholesterol	Total cholesterol (mmol/L)	Within 7 days of enrollment.
Secondary	Triglycerides	Triglycerides (mmol/L)	Within 7 days of enrollment.
Secondary	HDL-c	HDL-c (mmol/L)	Within 7 days of enrollment.
Secondary	LDL-c	LDL-c (mmol/L)	Within 7 days of enrollment.
Secondary	total testosterone	total testosterone (nmol/L)	Within 7 days of enrollment.
Secondary	free testosterone	free testosterone (nmol/L)	Within 7 days of enrollment.
Secondary	Sex hormone-binding globulin	Sex hormone-binding globulin (nmol/L)	Within 7 days of enrollment.
Secondary	Androstenedione	Androstenedione (ng/ml)	Within 7 days of enrollment.
Secondary	Dehydroepiandrosterone	Dehydroepiandrosterone (ug/dl)	Within 7 days of enrollment.