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Clinical Trials/NCT02190422
NCT02190422
Completed
Not Applicable

Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography

Nanjing Medical University1 site in 1 country200 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Assisted Reproductive Technology
Sponsor
Nanjing Medical University
Enrollment
200
Locations
1
Primary Endpoint
cardiovascular geometric morphology between controls and ART children
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile couples. However, the long-term effect of ART exposure on cardiovascular development and potential association with ART procedure and parental factors is confused. The aim is to shed more light on the pattern and extent of cardiovascular developmental alteration among ART children and its association with potential confounders.

Detailed Description

A historic cohort study was designed with prospective follow-up of ART children conceived in the Clinical Centre of Reproductive Medicine (CCRM) and born in Maternal-Fetal Medicine Unit (MFMU) of First Affiliated Hospital of Nanjing Medical University (FAHNMU) from 1 January 2002 to 31 December 2012. The present design is a prospective single-center study in FAHNMU. ART group will be recruited by a non-random, consecutive sample on the basis of the unique personal identification number assigned to ART children conceived in CCRM and born in MFMU. The controls will be recruited by a non-random, consecutive sample on the basis of the spontaneous conception population attending the MFMU of FAHNMU during the same period as ART group for prenatal screening and subsequent delivery considering their age.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
September 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Nanjing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Hong Liu

Principal Investigator

Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

  • the capability of complete examination of transthoracic echocardiography
  • the absence of complex cardiac malformations and systematic diseases.

Exclusion Criteria

  • the presence of a history of systemic diseases, frequent arrhythmias, and critical acquired heart diseases,
  • the presence of the background of familiar cardiomyopathy in their family,
  • limited acquisitions of echocardiographic imaging
  • poor image quality for assessment.

Outcomes

Primary Outcomes

cardiovascular geometric morphology between controls and ART children

Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Left ventricular end-diastolic diameters (LVDD) and end-systolic diameters (LVSD) will be measured by M-mode echocardiography at the para-sternal long-axis views. LV end-diastolic volume (LVEDV) and end-systolic volume(LVESV) will be calculated by 2D echocardiography from the apical four-chamber view using the modified Simpson's rule. Aorta diameters (AOD) and left atrial diameters (LAD) will be measured by 2D echocardiography at the para-sternal long-axis views. Left and right coronary artery will be measured by 2D echocardiography at the short-axis views. The interventricular septum thickness (IVST) and the left ventricular posterior wall thickness (LVPWT) will be measured by M mode from a para-sternal long-axis view. Left ventricular relative wall thickness (LVRWT) will be calculated the following equation: (IVST+PWT)/ LVDD.

Secondary Outcomes

  • cardiac function between controls and ART children(participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Study Sites (1)

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