<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02190422</url>
  </required_header>
  <id_info>
    <org_study_id>2012CB944902</org_study_id>
    <nct_id>NCT02190422</nct_id>
  </id_info>
  <brief_title>Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography</brief_title>
  <acronym>Heart and ART</acronym>
  <official_title>Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile&#xD;
      couples. However, the long-term effect of ART exposure on cardiovascular development and&#xD;
      potential association with ART procedure and parental factors is confused. The aim is to shed&#xD;
      more light on the pattern and extent of cardiovascular developmental alteration among ART&#xD;
      children and its association with potential confounders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A historic cohort study was designed with prospective follow-up of ART children conceived in&#xD;
      the Clinical Centre of Reproductive Medicine (CCRM) and born in Maternal-Fetal Medicine Unit&#xD;
      (MFMU) of First Affiliated Hospital of Nanjing Medical University (FAHNMU) from 1 January&#xD;
      2002 to 31 December 2012.&#xD;
&#xD;
      The present design is a prospective single-center study in FAHNMU. ART group will be&#xD;
      recruited by a non-random, consecutive sample on the basis of the unique personal&#xD;
      identification number assigned to ART children conceived in CCRM and born in MFMU.&#xD;
&#xD;
      The controls will be recruited by a non-random, consecutive sample on the basis of the&#xD;
      spontaneous conception population attending the MFMU of FAHNMU during the same period as ART&#xD;
      group for prenatal screening and subsequent delivery considering their age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>cardiovascular geometric morphology between controls and ART children</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 3 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiac function between controls and ART children</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 3 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Assisted Reproductive Technology</condition>
  <eligibility>
    <study_pop>
      <textblock>
        ART group will be ART children conceived in Clinical Centre of Reproductive Medicine and&#xD;
        born in Maternal-Fetal Medicine Unit (MFMU). The controls will be the spontaneous&#xD;
        conception children born in the MFMU during the same period as ART group for prenatal&#xD;
        screening and subsequent delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the capability of complete examination of transthoracic echocardiography&#xD;
&#xD;
          -  the absence of complex cardiac malformations and systematic diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of a history of systemic diseases, frequent arrhythmias, and critical&#xD;
             acquired heart diseases,&#xD;
&#xD;
          -  the presence of the background of familiar cardiomyopathy in their family,&#xD;
&#xD;
          -  limited acquisitions of echocardiographic imaging&#xD;
&#xD;
          -  poor image quality for assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Philips Ultrasound</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/?term=Association+between+assisted+reproductive+technology+and+cardiac+alteration+at+age+5+years.</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>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.</citation>
    <PMID>25915111</PMID>
  </results_reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>May 25, 2016</last_update_submitted>
  <last_update_submitted_qc>May 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>reproductive technologies, assisted</keyword>
  <keyword>echocardiography</keyword>
  <keyword>cardiology</keyword>
  <keyword>pediatrics</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02190422
org study id: 2012CB944902
nct id: NCT02190422
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: cardiovascular geometric morphology between controls and ART children
time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
description: 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.
measure: cardiac function between controls and ART children
time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
facility: 
country: China
url: http://www.ncbi.nlm.nih.gov/pubmed/?term=Association+between+assisted+reproductive+technology+and+cardiac+alteration+at+age+5+years.
description: Related Info
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: Principal Investigator