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

NCT ID: NCT02190422

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Assisted Reproductive Technology

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Philips Ultrasound

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 25915111 (View on PubMed)

Related Links

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Other Identifiers

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2012CB944902

Identifier Type: -

Identifier Source: org_study_id

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