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

Assisted Reproductive Technology Clinical Trial

— Heart and ART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190422
• Other study ID #: 2012CB944902
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: May 25, 2016
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: May 2016
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of HealthChina: Ministry of Science and Technology
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Assisted Reproductive Technology

Locations

Country	Name	City	State
China	Philips Ultrasound	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Liu H, Zhang Y, Gu HT, Feng QL, Liu JY, Zhou J, Yan F. Association between assisted reproductive technology and cardiac alteration at age 5 years. JAMA Pediatr. 2015 Jun;169(6):603-5. doi: 10.1001/jamapediatrics.2015.0214. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular geometric morphology between controls and ART children	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 modi?ed 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	Yes
Secondary	cardiac function between controls and ART children	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: p/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	Yes

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