NCT00993369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

4 years

First QC Date

October 8, 2009

Last Update Submit

November 8, 2016

Conditions

Neuro Developmental Delay

Keywords

Prediction of neuro developmental delay

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies

    Holter monitor/2 aims

    2 to 6 hours

Study Arms (2)

Healthy newborns conceived naturally

Other: Holter monitor

Healthy newborns conceived with IVF

Other: Holter monitor

Interventions

Holter monitorOTHER

Record heart rate for 2 to 6 hours on day of life 1 or 2.

Healthy newborns conceived naturallyHealthy newborns conceived with IVF

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Fetus and newborns.

You may qualify if:

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

You may not qualify if:

  • Twins
  • Genetic anomaly
  • Congenital malformation
  • Need for special care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Medical Center

Salt LakeCity, Utah, 84113, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 12, 2009

Study Start

July 1, 2006

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

US(1)