Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies (HRV ART)
This study is currently recruiting participants.
Verified June 2012 by University of Utah
Sponsor:
University of Utah
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00993369
First received: October 8, 2009
Last updated: June 4, 2012
Last verified: June 2012
| Tracking Information | |||||
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| First Received Date ICMJE | October 8, 2009 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00993369 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies | ||||
| Official Title ICMJE | Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Fetus and newborns. |
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| Condition ICMJE | Neuro Developmental Delay | ||||
| Intervention ICMJE | Other: Holter monitor
Record heart rate for 2 to 6 hours on day of life 1 or 2. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 1 Day | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00993369 | ||||
| Other Study ID Numbers ICMJE | 00018811 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Elizabeth Saarel MD, University of Utah | ||||
| Study Sponsor ICMJE | University of Utah | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Utah | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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