Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 7:39 PM
Study NCT ID:
NCT06325969
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCOS Patients' Immune Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': '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.'}, {'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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Homeostasis model assessment of insulin resistance', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'insulin resistance index'}, {'measure': 'body mass index', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'body mass index (kg/m2)'}, {'measure': 'menstrual frequency', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'number of menstruation in a year'}, {'measure': 'fasting glucose', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'fasting glucose (mmol/L)'}, {'measure': 'fasting insulin', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'fasting insulin (mmol/L)'}, {'measure': 'Total cholesterol', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Total cholesterol (mmol/L)'}, {'measure': 'Triglycerides', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Triglycerides (mmol/L)'}, {'measure': 'HDL-c', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'HDL-c (mmol/L)'}, {'measure': 'LDL-c', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'LDL-c (mmol/L)'}, {'measure': 'total testosterone', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'total testosterone (nmol/L)'}, {'measure': 'free testosterone', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'free testosterone (nmol/L)'}, {'measure': 'Sex hormone-binding globulin', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Sex hormone-binding globulin (nmol/L)'}, {'measure': 'Androstenedione', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Androstenedione (ng/ml)'}, {'measure': 'Dehydroepiandrosterone', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Dehydroepiandrosterone (ug/dl)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrom', 'Metformin', 'Immune Function']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women older than 18 years or younger than 45 years.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female subjects aged 18-45 years;\n* Voluntarily participate in the experiment, willing to sign the informed consent.\n* 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).\n\nExclusion Criteria:\n\n* Female patients younger than 18 years old or older than 45 years old;\n* Ovulation disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction (hyperthyroidism, hypothyroidism);\n* Congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, adrenal tumors, and other diseases causing hyperandrogenemia;\n* Severe liver and kidney dysfunction (more than 3 times the normal value)\n* Type 1 diabetes, monogenic mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes;\n* History of malignant tumor;\n* Severe infection, severe anemia, neutropenia, and other chronic diseases of the system;\n* Patients undergoing total hysterectomy or ovarian adnexectomy;\n* Mental illness, dementia, or other cognitive behavioral problems;\n* 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;\n* 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.\n* Pregnant or lactating patients;\n* Female patients with a BMI less than 20kg/m2."}, 'identificationModule': {'nctId': 'NCT06325969', 'briefTitle': "PCOS Patients' Immune Alterations", 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'PCOS Immune'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with PCOS', 'description': 'Women aged 18 to 45 who meet the 2003 Rotterdam criteria for PCOS.', 'interventionNames': ['Diagnostic Test: Detect the immune function of peripheral blood samples']}, {'label': 'Women without PCOS', 'description': 'Non-PCOS women aged 18 to 45.', 'interventionNames': ['Diagnostic Test: Detect the immune function of peripheral blood samples']}], 'interventions': [{'name': 'Detect the immune function of peripheral blood samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients.', 'armGroupLabels': ['Women with PCOS', 'Women without PCOS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'country': 'China', 'facility': "Department of Endocrinology, Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Manna Zhang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}