<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/NCT02203318</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0385</org_study_id>
    <nct_id>NCT02203318</nct_id>
  </id_info>
  <brief_title>Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to verify whether the hypertrophy of contralateral testis may&#xD;
      predict the absence of the non-palpable testis in the boys younger than 24months of age.&#xD;
      According to the previous studies of other countries, the large size of the contralateral&#xD;
      testis of the nonpalpable testis has positive correlation woth the weak viability of the&#xD;
      affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups&#xD;
      are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but&#xD;
      not normally descended testis group(group2) and control group(group3). The size of testis&#xD;
      will be measured with Ultrasound and the length, width and the height will be measured before&#xD;
      surgery at outpatient department. For the group 1 &amp; 2, the viability of the affected testis&#xD;
      will be evaluated and compared after surgery. In addition the comparison with normal control&#xD;
      group is also going th be conducted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Size of contralateral testis</measure>
    <time_frame>1 day of initial visit</time_frame>
    <description>The testicular size is measured 3-dimensionally with ultrasonography. The length, width and height will be measured and the volume of testis will be evaluated.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Focus of Study</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>healthy children with normal bilateral testis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>undescended palpable testis</arm_group_label>
    <description>patient whose affected testis is not descended to the normal position but palpable and exist intact in the upper area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-paplpable testis</arm_group_label>
    <description>patient whose affected testis is not palpable during the physical examination</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        totally, 72 children : unpalpable testis : 24 children, palpable undescended testis : 24&#xD;
        children, normal control : 24 children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. neonates or Infants who visited the out-patient clinic with nonpalpable or undescended&#xD;
             testis.(group 1, 2) aged from 6months to 18months&#xD;
&#xD;
          2. neonates or Infants aged from 6months to 18months with normal testis (volunteers,&#xD;
             Group3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. previous history of hormonal therapy.&#xD;
&#xD;
          2. chromosomal abnormality&#xD;
&#xD;
          3. previous history of abdomen or inguinal area surgery&#xD;
&#xD;
          4. children diagnosed with epididymitis or orchitis&#xD;
&#xD;
          5. twin baby&#xD;
&#xD;
          6. infants with premature (&lt;37 weeks) birth history&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>October 31, 2016</last_update_submitted>
  <last_update_submitted_qc>October 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cryptorchidism, undescended testis, hypertrophy of contralateral testis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02203318
org study id: 4-2014-0385
nct id: NCT02203318
lead sponsor: 
has dmc: No
The aim of this study is to verify whether the hypertrophy of contralateral testis may
      predict the absence of the non-palpable testis in the boys younger than 24months of age.
      According to the previous studies of other countries, the large size of the contralateral
      testis of the nonpalpable testis has positive correlation woth the weak viability of the
      affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups
      are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but
      not normally descended testis group(group2) and control group(group3). The size of testis
      will be measured with Ultrasound and the length, width and the height will be measured before
      surgery at outpatient department. For the group 1 & 2, the viability of the affected testis
      will be evaluated and compared after surgery. In addition the comparison with normal control
      group is also going th be conducted.
observational model: Case-Control
time perspective: Prospective
measure: Size of contralateral testis
time frame: 1 day of initial visit
description: The testicular size is measured 3-dimensionally with ultrasonography. The length, width and height will be measured and the volume of testis will be evaluated.
arm group label: control
description: healthy children with normal bilateral testis
arm group label: undescended palpable testis
description: patient whose affected testis is not descended to the normal position but palpable and exist intact in the upper area
arm group label: non-paplpable testis
description: patient whose affected testis is not palpable during the physical examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 6 Months
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertrophy