Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT05906966
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2023-03-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive, Emotional, Communicative, and Motor Development in Children Born From IOC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 377}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive development', 'timeFrame': '18 YEARS', 'description': 'Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare cognitive development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.'}, {'measure': 'Communicative development', 'timeFrame': '18 YEARS', 'description': 'Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare communicative development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.'}, {'measure': 'Motor development', 'timeFrame': '18 YEARS', 'description': 'Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare motor development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.'}, {'measure': 'Emotional development', 'timeFrame': '18 YEARS', 'description': 'Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare emotional development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ART', 'Child Development']}, 'descriptionModule': {'briefSummary': 'The study focuses on children born after in vitro fertilization (IVF) of cryopreserved oocytes.', 'detailedDescription': '* Evaluate whether the cognitive development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.\n* Evaluate whether the emotional development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.\n* Evaluate whether the communicative development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.\n* Evaluate whether the motor development of children born by IVF of cryopreserved oocytes is comparable to expected peer development'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Live births from pregnancies resulted from fresh and frozen embryo transfer after fertilization of cryopreserved oocytes are included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Live births from pregnancies resulted from fresh and frozen embryo transfer after fertilization of cryopreserved oocytes are included.\n\nExclusion Criteria:\n\n* Children born from pregnancies obtained from cryopreserved donated oocytes have been excluded.'}, 'identificationModule': {'nctId': 'NCT05906966', 'briefTitle': 'Cognitive, Emotional, Communicative, and Motor Development in Children Born From IOC', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Cognitive, Emotional, Communicative, and Motor Development in Children Born From in Vitro Fertilization of Cryopreserved Oocytes', 'orgStudyIdInfo': {'id': '1234567'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CHILDREN', 'description': 'BORN FROM IN VITRO FERTILIZATION OF CRYOPRESERVED OOCYTES', 'interventionNames': ['Other: Phone contact']}], 'interventions': [{'name': 'Phone contact', 'type': 'OTHER', 'description': '. All mothers of children of born from cryopreserved oocytes will be contacted by phone and administered a questionnaire, to gather additional information about further psychomotor development of children.', 'armGroupLabels': ['CHILDREN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Paolo Emanuele Levi Setti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Clinico Humanitas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}