Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-01 @ 11:42 PM
Study NCT ID:
NCT06739759
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Hyperstimulation Syndrome Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevention of OHSS', 'timeFrame': 'within 3 weeks', 'description': 'prevention of symptoms of ovarian hyperstimulation syndrome as amount of ascites in litres by US'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OHSS', 'mild', 'Moderate', 'Severe'], 'conditions': ['Ovarian Hyper Stimulation Syndrome (OHSS)']}, 'descriptionModule': {'briefSummary': 'Ovarian hyperstimulation is a very hazardous complication of ICSI', 'detailedDescription': 'Ovarian hyperstimulation could be mild , moderate , severe or marked'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'women with PCOS coming for ICSI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with PCOS coming for ICSI\n\nExclusion Criteria:\n\n* Women who donnot have PCOS'}, 'identificationModule': {'nctId': 'NCT06739759', 'acronym': 'OHSS', 'briefTitle': 'Ovarian Hyperstimulation Syndrome Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'Prophylaxis Against Ovarian Hyperstimulation Syndrome in PCOS Women', 'orgStudyIdInfo': {'id': 'ovarian hyperstimulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'antagonist', 'description': 'patients with PCOS undergoing ICSI receiving antagonist protocol', 'interventionNames': ['Drug: Antagonist protocol for IVF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified agonist with additives', 'description': 'Patients with PCOS undergoing ICSI receiving modified agonist protocol with additives', 'interventionNames': ['Drug: Modified Agonist protocol for IVF with additive treatments as HCQ']}], 'interventions': [{'name': 'Antagonist protocol for IVF', 'type': 'DRUG', 'otherNames': ['Antagonist'], 'description': 'antagonist protocol with triggering by Decapeptyl', 'armGroupLabels': ['antagonist']}, {'name': 'Modified Agonist protocol for IVF with additive treatments as HCQ', 'type': 'DRUG', 'otherNames': ['modified agonist with additives'], 'description': 'giving additive drugs to agonist protocolas HCQ', 'armGroupLabels': ['Modified agonist with additives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, MD', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '01002611058'}], 'facility': 'Aljazeerah hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, master', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Elgazzar, M.D', 'role': 'CONTACT', 'phone': '+201014005959'}, {'name': 'Mahmoud Alalfy, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Algazeerah', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Mahmoud Alalfy, MD', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '01002611058'}, {'name': 'Ahmed Elgazzar, MD', 'role': 'CONTACT', 'email': 'elgazzara50@gmail.com', 'phone': '01014005959'}], 'overallOfficials': [{'name': 'Mahmoud Alalfy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aljazeera Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'National Research centre', 'investigatorFullName': 'Mahmoud Alalfy', 'investigatorAffiliation': 'Aljazeera Hospital'}}}}