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

NCT02190422 | Completed DMC

• 1 other identifier: 2012CB944902
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Assisted Reproductive Technology

Keywords

reproductive technologies, assisted; echocardiography; cardiology; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (1)

• cardiac function between controls and ART children

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

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Philips Ultrasound

Nanjing, Jiangsu, 210000, China

Location

Related 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. No abstract available.

  PMID: 25915111 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 15, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

CN (1)