Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography (Heart and ART)

May 25, 2016 updated by: Hong Liu, Nanjing Medical University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

200

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Philips Ultrasound

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

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ART group will be ART children conceived in Clinical Centre of Reproductive Medicine and born in Maternal-Fetal Medicine Unit (MFMU). The controls will be the spontaneous conception children born in the MFMU during the same period as ART group for prenatal screening and subsequent delivery.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac function between controls and ART children
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
LV shortening fraction will be calculated from internal ventricular diameters obtained from a para-sternal long-axis view by M mode using the following equation: (end-diastolic diameter-end-systolic diameter)/end-diastolic diameter. LV stroke volumes will be calculated as follows: π/4×(aortic valve diameter)2×(aortic artery systolic flow velocity-time integral). Left ejection fraction will be calculated as follows: (end-diastolic volume-end-systolic volume)/end-diastolic volume. Left cardiac outputs will be calculated as stroke volume times heart rate. Left cardiac index will be normalized as cardiac outputs/ BSA.
participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

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

Sponsor

Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012CB944902

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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