Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-21 @ 2:40 PM
Study NCT ID:
NCT02026193
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2013-12-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'skol@rambam.health.gov.il', 'phone': '97247773232', 'title': 'Dr Shahar Kol , Director IVF Unit', 'organization': 'Rambam health Care campus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oocyte Vitrification', 'description': 'All retrieved mature oocytes will be vitrified.\n\noocyte vitrification', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Embryo Freezing', 'description': 'All retrieved oocytes will be fertilized, and resulting embryos will be frozen.\n\nembryo freezing', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fetal Heart Activity 1 Month Post Embryo Transfer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oocyte Vitrification', 'description': 'All retrieved mature oocytes will be vitrified.\n\noocyte vitrification'}, {'id': 'OG001', 'title': 'Embryo Freezing', 'description': 'All retrieved oocytes will be fertilized, and resulting embryos will be frozen.\n\nembryo freezing'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after embryo transfer', 'description': 'Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer', 'unitOfMeasure': 'participants with fetal heart activity', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oocyte Vitrification', 'description': 'All retrieved mature oocytes will be vitrified.\n\noocyte vitrification'}, {'id': 'FG001', 'title': 'Embryo Freezing', 'description': 'All retrieved oocytes will be fertilized, and resulting embryos will be frozen.\n\nembryo freezing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oocyte Vitrification', 'description': 'All retrieved mature oocytes will be vitrified.\n\noocyte vitrification'}, {'id': 'BG001', 'title': 'Embryo Freezing', 'description': 'All retrieved oocytes will be fertilized, and resulting embryos will be frozen.\n\nembryo freezing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '25', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2013-12-30', 'resultsFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2013-12-31', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-20', 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal Heart Activity 1 Month Post Embryo Transfer', 'timeFrame': '1 month after embryo transfer', 'description': 'Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '21828116', 'type': 'BACKGROUND', 'citation': 'Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'The chances to achieve pregnancy after retrieving \\>15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.\n\nThe purpose of this study is to compare the outcome of these two approaches.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IVF patients\n* ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or \\>15 oocytes.\n* Normal uterus\n\nExclusion Criteria:\n\n* \\<20% fertilization rate'}, 'identificationModule': {'nctId': 'NCT02026193', 'briefTitle': 'IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'orgStudyIdInfo': {'id': 'RMB-0439-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oocyte vitrification', 'description': 'All retrieved mature oocytes will be vitrified.', 'interventionNames': ['Procedure: oocyte vitrification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'embryo freezing', 'description': 'All retrieved oocytes will be fertilized, and resulting embryos will be frozen.', 'interventionNames': ['Procedure: embryo freezing']}], 'interventions': [{'name': 'oocyte vitrification', 'type': 'PROCEDURE', 'armGroupLabels': ['oocyte vitrification']}, {'name': 'embryo freezing', 'type': 'PROCEDURE', 'armGroupLabels': ['embryo freezing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'state': 'Israel', 'country': 'Israel', 'facility': 'IVF Unit, Rambam medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, IVF Unit', 'investigatorFullName': 'Shahar Kol MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}