Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-11 @ 7:03 AM
Study NCT ID:
NCT00993369
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2009-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2009-10-08', 'studyFirstSubmitQcDate': '2009-10-09', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies', 'timeFrame': '2 to 6 hours', 'description': 'Holter monitor/2 aims'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prediction of neuro developmental delay'], 'conditions': ['Neuro Developmental Delay']}, 'descriptionModule': {'briefSummary': 'This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.', 'detailedDescription': 'This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fetus and newborns.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fetus or newborn\n* Delivery at University of Utah Medical Center, Latter Day Saints Hospital or Intermountain Medical Center\n\nExclusion Criteria:\n\n* Twins\n* Genetic anomaly\n* Congenital malformation\n* Need for special care'}, 'identificationModule': {'nctId': 'NCT00993369', 'acronym': 'HRV ART', 'briefTitle': 'Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies', 'orgStudyIdInfo': {'id': '00018811'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy newborns conceived naturally', 'interventionNames': ['Other: Holter monitor']}, {'label': 'Healthy newborns conceived with IVF', 'interventionNames': ['Other: Holter monitor']}], 'interventions': [{'name': 'Holter monitor', 'type': 'OTHER', 'description': 'Record heart rate for 2 to 6 hours on day of life 1 or 2.', 'armGroupLabels': ['Healthy newborns conceived naturally', 'Healthy newborns conceived with IVF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84113', 'city': 'Salt LakeCity', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}