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

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00993369
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 48
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	Phase
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 Design

• 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: Jul 1, 2006
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies [2 to 6 hours]

   Holter monitor/2 aims

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Day
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Utah Medical Center	Salt LakeCity	Utah	United States	84113

Sponsors and Collaborators

• University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT00993369
• Other Study ID Numbers: 00018811
• First Posted: Oct 12, 2009
• Last Update Posted: Nov 10, 2016
• Last Verified: Nov 1, 2016

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

Study Results

No Results Posted as of Nov 10, 2016