<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/NCT02255396</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-209</org_study_id>
    <nct_id>NCT02255396</nct_id>
  </id_info>
  <brief_title>Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia</brief_title>
  <official_title>Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia</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>
      Estradiol and Testosterone are two important hormones for the regulation of an effective&#xD;
      spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in&#xD;
      seminal plasma of men with non-obstructive azoospermia may be a predictive test before&#xD;
      surgical testicular biopsy to determine the chance of a positive sperm extraction to use for&#xD;
      ICSI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to compare the levels of esttradiol and testosterone in seminal&#xD;
      plasma of men with non-obstructive azoospermia. Indeed, for these patients, none biological&#xD;
      test allows to predict a positive sperm extraction before the surgical testis biopsy is&#xD;
      performed. Since the involvement of estradiol and testosterone in the regulation of&#xD;
      spermatogenesis, the measurement of these hormones in seminal plasma may be a predictive tool&#xD;
      for these men before testis biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia</measure>
    <time_frame>at 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Issue of testicular biopsy (sperm extraction positive or negative)</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degrees of alteration of testis histology</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum levels of estradiol and testosterone</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ESTRADIOL</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        azoospermia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Azoospermia confirmed by two semen analysis (at minimum 74 days between the both&#xD;
             analysis)&#xD;
&#xD;
          -  Volume of seminal plasma &gt;0.6ml&#xD;
&#xD;
          -  Testicular biopsy one month after the last semen analysis&#xD;
&#xD;
          -  Informed consent signed by the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  obstructive azoospermia&#xD;
&#xD;
          -  cryptozoospermia&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 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>Azoospermia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol</mesh_term>
  </intervention_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/NCT02255396
org study id: CHU-209
nct id: NCT02255396
lead sponsor: 
Estradiol and Testosterone are two important hormones for the regulation of an effective
      spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in
      seminal plasma of men with non-obstructive azoospermia may be a predictive test before
      surgical testicular biopsy to determine the chance of a positive sperm extraction to use for
      ICSI.
The aim of this study is to compare the levels of esttradiol and testosterone in seminal
      plasma of men with non-obstructive azoospermia. Indeed, for these patients, none biological
      test allows to predict a positive sperm extraction before the surgical testis biopsy is
      performed. Since the involvement of estradiol and testosterone in the regulation of
      spermatogenesis, the measurement of these hormones in seminal plasma may be a predictive tool
      for these men before testis biopsy.
time perspective: Cross-Sectional
measure: Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia
time frame: at 1 month
measure: Issue of testicular biopsy (sperm extraction positive or negative)
time frame: at day 1
measure: Degrees of alteration of testis histology
time frame: at day 1
measure: Serum levels of estradiol and testosterone
time frame: at day 1
intervention type: Other
intervention name: ESTRADIOL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Azoospermia
mesh term: Estradiol