<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/NCT02235103</url>
  </required_header>
  <id_info>
    <org_study_id>B670201316616</org_study_id>
    <nct_id>NCT02235103</nct_id>
  </id_info>
  <brief_title>The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.</brief_title>
  <acronym>DNAFRAG</acronym>
  <official_title>The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <brief_summary>
    <textblock>
      Recent research has revealed that subtle abnormalities can be found in sperm samples that&#xD;
      seem to be normal with conventional analysis techniques. The DNA in the sperm heads is&#xD;
      sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained&#xD;
      infertility do not achieve pregnancy.&#xD;
&#xD;
      We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples&#xD;
      with previously unexplained infertility. In a first treatment cycle with intra-uterine&#xD;
      insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the&#xD;
      results of the patients who are pregnant will be compared with those of the not pregnant&#xD;
      ones. We expect to find differences between both groups.&#xD;
&#xD;
      100 patients will be included in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>2 1/2 weeks after insemination</time_frame>
    <description>Ultrasound to diagnose intra-uterine pregnancy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>20 weeks after insemination</time_frame>
    <description>Ultrasound to diagnose an evolutive pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>42 weeks after insemination</time_frame>
    <description>Clinical report of the delivery by the obstetrician</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Unexplained Infertility</condition>
  <arm_group>
    <arm_group_label>Clinical Pregnancy</arm_group_label>
    <description>Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Clinical Pregnancy</arm_group_label>
    <description>Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sperm Chromatin Dispersion Test</intervention_name>
    <arm_group_label>Clinical Pregnancy</arm_group_label>
    <arm_group_label>No Clinical Pregnancy</arm_group_label>
    <other_name>Halosperm®</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sperm samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with unexplained fertility treated with intra-uterine insemination (first cycle)&#xD;
        and ovulation induction with clomiphene citrate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unexplained infertility, i.e. female patients with ovulatory cycles and patent tubes;&#xD;
             normal sperm analysis (WHO criteria).&#xD;
&#xD;
          -  Patient agrees to have a first treatment cycle with intra-uterine insemination and&#xD;
             ovulation-induction with clomiphene citrate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Vandekerckhove, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fertility Centre, University Hospital Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fertility Centre of the University Hospital</name>
      <address>
        <city>Ghent</city>
        <state>East Flanders</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>March 11, 2016</last_update_submitted>
  <last_update_submitted_qc>March 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 14, 2016</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/NCT02235103
org study id: B670201316616
nct id: NCT02235103
lead sponsor: 
Recent research has revealed that subtle abnormalities can be found in sperm samples that
      seem to be normal with conventional analysis techniques. The DNA in the sperm heads is
      sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained
      infertility do not achieve pregnancy.

      We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples
      with previously unexplained infertility. In a first treatment cycle with intra-uterine
      insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the
      results of the patients who are pregnant will be compared with those of the not pregnant
      ones. We expect to find differences between both groups.

      100 patients will be included in the study.
observational model: Cohort
time perspective: Prospective
measure: Clinical pregnancy rate
time frame: 2 1/2 weeks after insemination
description: Ultrasound to diagnose intra-uterine pregnancy
measure: Ongoing pregnancy rate
time frame: 20 weeks after insemination
description: Ultrasound to diagnose an evolutive pregnancy.
measure: Live birth rate
time frame: 42 weeks after insemination
description: Clinical report of the delivery by the obstetrician
arm group label: Clinical Pregnancy
description: Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination.
arm group label: No Clinical Pregnancy
description: Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination.
intervention type: Other
intervention name: Sperm Chromatin Dispersion Test
arm group label: Clinical Pregnancy
arm group label: No Clinical Pregnancy
other name: Halosperm®
Sperm samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Frank Vandekerckhove, MD
role: Principal Investigator
affiliation: Fertility Centre, University Hospital Ghent
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Infertility