<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/NCT02252510</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0208</org_study_id>
    <nct_id>NCT02252510</nct_id>
  </id_info>
  <brief_title>Reliability for the Detection of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)</brief_title>
  <official_title>Evaluation of the Reliability for the Measurement of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This&#xD;
      measurement helps to better diagnose male infertility and seems easy to apply in routine.&#xD;
      However, the reliability of this method needs to be evaluated before applying for clinical&#xD;
      practice in andrology laboratory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to measure the inter and intra-observer reliability for the&#xD;
      measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold&#xD;
      standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling)&#xD;
      method. However, this method is not easy to apply in routine. Therefore we investigate to&#xD;
      analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of sperm DNA damage measured by TUNEL method</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Infertile Men</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HALOSPERM</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        infertile men&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infertile men&#xD;
&#xD;
          -  &lt;50 years&#xD;
&#xD;
          -  with at least 5.106spermatozoa/ml in the ejacu&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  azoospermia&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>September 26, 2014</last_update_submitted>
  <last_update_submitted_qc>September 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT02252510
org study id: CHU-0208
nct id: NCT02252510
lead sponsor: 
It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This
      measurement helps to better diagnose male infertility and seems easy to apply in routine.
      However, the reliability of this method needs to be evaluated before applying for clinical
      practice in andrology laboratory.
The aim of this study is to measure the inter and intra-observer reliability for the
      measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold
      standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling)
      method. However, this method is not easy to apply in routine. Therefore we investigate to
      analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.
time perspective: Prospective
measure: - Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)
time frame: at day 1
measure: Percentage of sperm DNA damage measured by TUNEL method
time frame: at day 1
intervention type: Other
intervention name: HALOSPERM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Infertility