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

November 8, 2016 updated by: University of Utah
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt LakeCity, Utah, United States, 84113
        • University of Utah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fetus and newborns.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
Time Frame: 2 to 6 hours
Holter monitor/2 aims
2 to 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (Estimate)

October 12, 2009

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00018811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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