Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-03-04 @ 12:03 PM
Study NCT ID:
NCT02784457
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2016-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of women who needed culdocentesis or paracentesis of the ascitic fluid', 'timeFrame': 'within 2 weeks of onset'}], 'secondaryOutcomes': [{'measure': 'Number of women who needed hospitalization', 'timeFrame': 'within 2 weeks of onset of symptoms'}, {'measure': 'Time to regression of nausea/vomiting', 'timeFrame': 'within 2 weeks of onset of symptoms'}, {'measure': 'Time to regression of large ovarian size', 'timeFrame': 'within 4 weeks of onset of symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Assisted Reproduction']}, 'descriptionModule': {'briefSummary': 'Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe ovarian hyperstimulation syndrome and had cancelled embryo transfer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who develop early-onset severe ovarian hyperstimulation syndrome after controlled ovarian stimulation using long GnRH agonist protocol and hCG for triggering ovulation.\n\nExclusion Criteria:\n\n* Women on short or antagonist protocols.\n* Women who received GnRH agonist for triggering ovulation.\n* Women who had embryo transfer.'}, 'identificationModule': {'nctId': 'NCT02784457', 'briefTitle': 'Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DAT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GnRHant', 'description': 'women who received GnRH antagonist', 'interventionNames': ['Drug: Cetrorelix']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'women who did not receive GnRH antagonist'}], 'interventions': [{'name': 'Cetrorelix', 'type': 'DRUG', 'armGroupLabels': ['GnRHant']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Mohammed Faris', 'investigatorAffiliation': 'Ain Shams University'}}}}