Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT06290895
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2024-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Oocyte Activation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blastocyst rate', 'timeFrame': '5 days after oocyte fertilization', 'description': 'Likelihood of an oocyte fertilized to blastocyst stage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility', 'Ovarian Insufficiency']}, 'descriptionModule': {'briefSummary': 'Studies reported that calcium signal deficiency or insufficiency during oocyte activation are related with embryo arrest and blastocyst quality. The utilization of Artificial Oocyte Activation (AOA) is safe and does not increase birth defects, cognition, language and motor skills. AOA is the first line of treatment in patients with globozoospermia (round headed spermatozoa). Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists and comprises about 10-15% of patients undergoing controlled ovarian hyperstimulation. The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. The European Society of Human and REproduction (ESHRE) recommends AOA in cases with failed fertilization/ low fertilization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Data spreadsheet from 2018 to 2023 of patients having undergone an IVF cycle', 'genderDescription': 'Women able to have oocyte retrieval after in-vitro fertilization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with poor or no blastocyst development in their primary cycle\n* Group 1 - second cycle using AOA following the poor blastocyst development cycle\n* Group 2 - second cycle without AOA following the poor development cycle\n\nExclusion Criteria:\n\n* All cycles who do not have repeat cycles following the poor blastocyst development cycle'}, 'identificationModule': {'nctId': 'NCT06290895', 'briefTitle': 'Artificial Oocyte Activation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinique Ovo'}, 'officialTitle': 'The Effect of Artificial Oocyte Activation on Blastocysts Rate in Patients With Low Fertilization Rate', 'orgStudyIdInfo': {'id': '3465'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'In-vitro fertilization (IVF) cycle using artificial oocyte activation (AOA)', 'interventionNames': ['Other: women having had a second IVF cycle with AOA']}, {'label': 'In-vitro fertilization (IVF) cycle without artificial oocyte activation (AOA)'}], 'interventions': [{'name': 'women having had a second IVF cycle with AOA', 'type': 'OTHER', 'description': 'The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. Physiological oocyte activation requires a sperm-derived enzyme called phospholipase C zeta to cause the release of calcium in the form of oscillations from internal storages.', 'armGroupLabels': ['In-vitro fertilization (IVF) cycle using artificial oocyte activation (AOA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4P 2S4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Ovo', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Simon Phillips, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Ovo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Ovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}