Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-03-14 @ 1:25 AM
Study NCT ID:
NCT03044756
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of retrieved oocytes', 'timeFrame': 'One Month', 'description': 'total number and maturation of the retrieved oocytes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GnRH antagonist', 'Pituitary downregulation', 'IVF', 'ICSI'], 'conditions': ['Pituitary Downregulation']}, 'referencesModule': {'references': [{'pmid': '23875164', 'type': 'BACKGROUND', 'citation': 'Chang HJ, Lee JR, Jee BC, Suh CS, Lee WD, Kim SH. Cessation of gonadotropin-releasing hormone antagonist on triggering day in flexible multiple-dose protocol: A randomized controlled study. Clin Exp Reprod Med. 2013 Jun;40(2):83-9. doi: 10.5653/cerm.2013.40.2.83. Epub 2013 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women. We will study the impact of omitting the antagonist dose in a prospective randomized trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All antagonist cycle ivf who agree to participate\n\nExclusion Criteria:\n\n* expected poor responders.'}, 'identificationModule': {'nctId': 'NCT03044756', 'briefTitle': 'Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Omitting GnR-antagonist on Ovulation Trigger Day in the Fresh Autologous IVF/ICSI Cycles', 'orgStudyIdInfo': {'id': 'Omit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '-ve arm', 'description': 'The women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm)', 'interventionNames': ['Drug: Omit Citrotide 0.25 dose on the day of triggering of ovulation']}, {'type': 'NO_INTERVENTION', 'label': '+ve arm', 'description': 'The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol)'}], 'interventions': [{'name': 'Omit Citrotide 0.25 dose on the day of triggering of ovulation', 'type': 'DRUG', 'description': 'Omit Citrotide 0.25 dose on the day of triggering of ovulation', 'armGroupLabels': ['-ve arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'state': 'Non-US/Non-Canadian', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Osama Abdalmageed', 'role': 'CONTACT', 'email': 'drosamast1981@gmail.com', 'phone': '1007972027'}], 'facility': 'Osama Abdalmageed', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '71111', 'city': 'Asyut', 'state': 'Non-US/Non-Canadian', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Osama Abdalmageed', 'role': 'CONTACT', 'email': 'drosamast1981@gmail.com'}], 'facility': 'Osama Abdalmageed', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The regulations in Assiut University do not allow protected patient data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity', 'investigatorFullName': 'Osama Saber Thabet Abdalmageed', 'investigatorAffiliation': 'Assiut University'}}}}