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

N

Nanjing Medical University

Status

Completed

Conditions

Assisted Reproductive Technology

Study type

Observational

Funder types

Other

Identifiers

NCT02190422
2012CB944902

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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