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

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.

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Key information

Conditions

Assisted Reproductive Technology Behavior Helping Behavior Social Behavior

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Philips Ultrasound

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Acronym: Heart and ART

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Jul 15, 2014
Registry last updated: May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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