Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 3:21 AM
Study NCT ID:
NCT06826495
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thiol Disulfide Balance and Oxidative Stress Change in Endometrial Polyp Patients
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': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Total antioxidant status (μmol Trolox equivalent/ L)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Total oxidant status (μmol H2O2 equivalent/L)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Oxidative stress index (arbitrary unit)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Paraoxonase (U/L)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Arylesterase (Ku/l)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Total thiol (µmol / L)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Native thiol (µmol / L) / alb (g / l)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Disulfide (-S-S-) (µmol / L) / alb (g/l)'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'From January 2021 to January 2022', 'description': 'Ischemia-modified albumin (u/L)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Polyp', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Changes in Thiol Disulfide Balance and Oxidative Stress Mechanisms in Patients with Endometrial Polyps'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of fifty-four participants, aged 20 to 48, took part in the study, including twenty-four women diagnosed with endometrial polyps and thirty women as the control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor participants in the control group:\n\n• To be without endometrial polyp\n\nFor the polyp group, they were as follows:\n\n* Individuals experiencing menometrorrhagia\n* A body mass index (BMI) of 25 or more\n* Hypertension\n* Endometrial polyps detected via saline infusion ultrasonography\n\nExclusion Criteria:\n\n* Pregnancy\n* Diabetes mellitus\n* Pelvic mass\n* Malignancy\n* The use of Tamoxifen, hormonal contraceptives, or hormone replacement therapy.'}, 'identificationModule': {'nctId': 'NCT06826495', 'briefTitle': 'Thiol Disulfide Balance and Oxidative Stress Change in Endometrial Polyp Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mardin Artuklu University'}, 'officialTitle': 'Thiol Disulfide Balance and Oxidative Stress Change in Endometrial Polyp Patients', 'orgStudyIdInfo': {'id': '10354421-2020/23-8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endometrial polyps', 'description': 'Women with endometrial polyp'}, {'label': 'control group', 'description': 'Participants in the control group were confirmed to be free of endometrial polyps via TVUSG and saline infusion ultrasonography'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Alanya Training and Research Hospital Gynecology and Obstetrics Department', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mardin Artuklu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hasan Basri Savas', 'investigatorAffiliation': 'Mardin Artuklu University'}}}}