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

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ClinicalTrials.gov Identifier: NCT00993369
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
University of Utah

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.

Condition or disease Intervention/treatment
Neuro Developmental Delay Other: Holter monitor

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.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
Study Start Date : July 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies [ Time Frame: 2 to 6 hours ]
    Holter monitor/2 aims



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993369


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

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00993369     History of Changes
Other Study ID Numbers: 00018811
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016

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