Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-28 @ 5:27 AM
Study NCT ID:
NCT02058212
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015032', 'term': 'Zinc'}, {'id': 'D012643', 'term': 'Selenium'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-07', 'studyFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma reactive oxygen species affection by antioxidant treatment', 'timeFrame': '3 months', 'description': 'measure before and 3months after antioxidant treatment'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '2 months', 'description': 'long protocol administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ICSI', 'antioxidants', 'ROS', 'endometriosis'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'ROS plays an essential role in the pathogenesis of many reproductive processes. High follicular fluid ROS levels are associated with negative IVF outcomes.\n\nis plasma level of reactive oxygen species is affected by antioxidant treatment in endometriotic women?', 'detailedDescription': 'Study design, size, duration: : prospective randomized controlled clinical trial 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . randomization was done by closed envelop single blind for patient Participants/materials, setting, methods: was done in the Egyptian centre for IVF from March 2013 to October 2013 . 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . all patients were subjected to plasma sample before start long protocol for induction and second on day of ovum pick up . embryo transfer was done according to embryo grading .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with endometriosis\n\nExclusion Criteria:\n\npatients with no endometriosis , not suitable for ICSI-'}, 'identificationModule': {'nctId': 'NCT02058212', 'acronym': 'ROS', 'briefTitle': 'Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome', 'orgStudyIdInfo': {'id': 'antioxidants for endometriosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'no antioxidant , ROS , pregnancy outcome', 'description': 'no anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) will be given to endometriotic women undergoing IVF', 'interventionNames': ['Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'antioxidant , ROS , pregnancy outcome', 'description': 'anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)', 'interventionNames': ['Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium']}], 'interventions': [{'name': 'ascorbate 1000mg, vitamin E 400, zinc and selenium', 'type': 'DRUG', 'description': 'anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) are given to half patients only before IVF , plasma level of ROS are detected before and on day of oocyte retrieval then correlated to pregnancy outcome', 'armGroupLabels': ['antioxidant , ROS , pregnancy outcome', 'no antioxidant , ROS , pregnancy outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Maadi', 'country': 'Egypt', 'facility': 'egyption centre for IVF', 'geoPoint': {'lat': 29.95958, 'lon': 31.25924}}, {'zip': '11451', 'city': 'Maadi', 'country': 'Egypt', 'geoPoint': {'lat': 29.95958, 'lon': 31.25924}}, {'zip': '1', 'city': 'Maadi', 'country': 'Egypt', 'geoPoint': {'lat': 29.95958, 'lon': 31.25924}}], 'overallOfficials': [{'name': 'olfat nouh riad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'olfat nouh riad', 'investigatorAffiliation': 'Cairo University'}}}}