Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-27 @ 10:19 PM
Study NCT ID:
NCT01607203
Status:
COMPLETED
Last Update Posted:
2015-02-19
First Post:
2012-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wim.decleer@janpalfijngent.be', 'phone': '+32 9 325 92 20', 'title': 'dr.Decleer Wim', 'phoneExt': '092248851', 'organization': 'AZ JAN PALFIJN'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'hCG TRIGGERING', 'description': 'TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'hCG and GnRH Agonist Triggering', 'description': 'DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL', 'otherNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'OHSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MII Oocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hCG TRIGGERING', 'description': 'TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL'}, {'id': 'OG001', 'title': 'hCG and GnRH Agonist Triggering', 'description': 'DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'the number of mature oocytes retrieved', 'unitOfMeasure': 'cumulus oocyte complex', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hCG Triggering', 'description': 'TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL'}, {'id': 'OG001', 'title': 'hCG and GnRH Agonist Triggering', 'description': 'DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'the number of pregnancies obtained, wich still is the most important issue for the patients', 'unitOfMeasure': 'pregnancies', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Cryopreserved Embryos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hCG Triggering', 'description': 'TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL'}, {'id': 'OG001', 'title': 'hCG and GnRH Agonist Triggering', 'description': 'DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 't -test'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'unitOfMeasure': 'patients with cryopreserved embryos', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'hCG Triggering', 'description': 'TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL'}, {'id': 'FG001', 'title': 'hCG and GnRH Agonist Triggering', 'description': 'DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'the Principal Investigator (PI) prescreened the patients and only the eligible patients were assigned to a group by the study coordinator'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HCG TRIGGERING', 'description': 'TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL'}, {'id': 'BG001', 'title': 'hCG and GnRH Agonist Triggering', 'description': 'DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '30.2', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'FEMALE', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '23.8', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '23.7', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2012-05-04', 'resultsFirstSubmitDate': '2013-12-30', 'studyFirstSubmitQcDate': '2012-05-24', 'lastUpdatePostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-03', 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MII Oocytes', 'timeFrame': '3 weeks', 'description': 'the number of mature oocytes retrieved'}], 'secondaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': '12 weeks', 'description': 'the number of pregnancies obtained, wich still is the most important issue for the patients'}, {'measure': 'Patients With Cryopreserved Embryos', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ovarian hyper stimulation syndrome (OHSS)', 'metaphase II oocytes (MII)', "good quality embryo's", 'implantation', 'pregnancy'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intra-cytoplasmic sperm injection (ICSI) patients below 38 years\n* 1,2 or 3 rd IVF-cycle\n\nExclusion Criteria:\n\n* polycystic ovary syndrome (PCOS) patients\n* patients with endocrinological diseases or problems'}, 'identificationModule': {'nctId': 'NCT01607203', 'briefTitle': 'Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist', 'organization': {'class': 'OTHER', 'fullName': 'AZ Jan Palfijn Gent'}, 'officialTitle': 'Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist', 'orgStudyIdInfo': {'id': 'Dr. Decleer Wim'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hCG', 'description': '5000 IU Pregnyl SC', 'interventionNames': ['Drug: pregnyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hCG and GnRH agonist', 'description': '5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC', 'interventionNames': ['Drug: Decapeptyl Daily', 'Drug: pregnyl']}], 'interventions': [{'name': 'Decapeptyl Daily', 'type': 'DRUG', 'otherNames': ['Gonapeptyl'], 'description': 'Decapeptyl 0.2 mg SC once 1day', 'armGroupLabels': ['hCG and GnRH agonist']}, {'name': 'pregnyl', 'type': 'DRUG', 'description': '5000 IU SC', 'armGroupLabels': ['hCG', 'hCG and GnRH agonist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-vlaanderen', 'country': 'Belgium', 'facility': 'A Z Jan Palfijn', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Wim Decleer, gynacologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVF Centrum Jan Palfijn Gent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Jan Palfijn Gent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Onze Lieve Vrouw Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'gynaecologist', 'investigatorFullName': 'Dr. Decleer Wim', 'investigatorAffiliation': 'AZ Jan Palfijn Gent'}}}}