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

Sponsor
Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT02190422
Collaborator
(none)
200
Enrollment
1
Location
3
Duration (Months)
66.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Sep 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. cardiovascular geometric morphology between controls and ART children [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 Outcome Measures

    1. cardiac function between controls and ART children [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Philips Ultrasound Nanjing Jiangsu China 210000

    Sponsors and Collaborators

    • Nanjing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Hong Liu, Principal Investigator, Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT02190422
    Other Study ID Numbers:
    • 2012CB944902
    First Posted:
    Jul 15, 2014
    Last Update Posted:
    May 27, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Hong Liu, Principal Investigator, Nanjing Medical University
    reproductive technologies, assisted
    echocardiography
    cardiology
    pediatrics

    Study Results

    No Results Posted as of May 27, 2016