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Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies (HRV ART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00993369
First received: October 8, 2009
Last updated: November 8, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Neuro Developmental Delay
Other: Holter monitor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies [ Time Frame: 2 to 6 hours ] [ Designated as safety issue: No ]
    Holter monitor/2 aims


Enrollment: 60
Study Start Date: July 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy newborns conceived naturally Other: Holter monitor
Record heart rate for 2 to 6 hours on day of life 1 or 2.
Healthy newborns conceived with IVF Other: Holter monitor
Record heart rate for 2 to 6 hours on day of life 1 or 2.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   up to 1 Day   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Fetus and newborns.
Criteria

Inclusion Criteria:

  • Fetus or newborn
  • Delivery at University of Utah Medical Center, Latter Day Saints Hospital or Intermountain Medical Center

Exclusion Criteria:

  • Twins
  • Genetic anomaly
  • Congenital malformation
  • Need for special care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993369

Locations
United States, Utah
University of Utah Medical Center
Salt LakeCity, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00993369     History of Changes
Other Study ID Numbers: 00018811 
Study First Received: October 8, 2009
Last Updated: November 8, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Prediction of neuro developmental delay

ClinicalTrials.gov processed this record on December 02, 2016