PCOS Patients Immune Status Evaluation

Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Function; Metformin; Polycystic Ovary Syndrom
• Intervention / Treatment: Diagnostic test: Detect the immune function of peripheral blood samples

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Manna Zhang, doctor; Phone Number: +8613774448495; Email: mannazhang@126.com

Study Locations

• China
  • Shanghai, China, 200072
    • Recruiting
    • Department of Endocrinology, Shanghai Tenth People's Hospital
    • Contact: Manna Zhang, Doctor; Phone Number: +86-021-66301004; Email: mannazhang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women older than 18 years or younger than 45 years.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with PCOS; Women aged 18 to 45 who meet the 2003 Rotterdam criteria for PCOS.	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.
Women without PCOS; Non-PCOS women aged 18 to 45.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homeostasis model assessment of insulin resistance	insulin resistance index	Within 7 days of enrollment.
body mass index	body mass index (kg/m2)	Within 7 days of enrollment.
menstrual frequency	number of menstruation in a year	Within 7 days of enrollment.
fasting glucose	fasting glucose (mmol/L)	Within 7 days of enrollment.
fasting insulin	fasting insulin (mmol/L)	Within 7 days of enrollment.
Total cholesterol	Total cholesterol (mmol/L)	Within 7 days of enrollment.
Triglycerides	Triglycerides (mmol/L)	Within 7 days of enrollment.
HDL-c	HDL-c (mmol/L)	Within 7 days of enrollment.
LDL-c	LDL-c (mmol/L)	Within 7 days of enrollment.
total testosterone	total testosterone (nmol/L)	Within 7 days of enrollment.
free testosterone	free testosterone (nmol/L)	Within 7 days of enrollment.
Sex hormone-binding globulin	Sex hormone-binding globulin (nmol/L)	Within 7 days of enrollment.
Androstenedione	Androstenedione (ng/ml)	Within 7 days of enrollment.
Dehydroepiandrosterone	Dehydroepiandrosterone (ug/dl)	Within 7 days of enrollment.

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Manna Zhang, doctor, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 8, 2026

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome
• Other Study ID Numbers: PCOS Immune

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No