<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/NCT02214537</url>
  </required_header>
  <id_info>
    <org_study_id>MADDA12201301</org_study_id>
    <nct_id>NCT02214537</nct_id>
  </id_info>
  <brief_title>Does DNA Sperm Fragmentation Affects Embryo Morphokinetic?</brief_title>
  <acronym>MACs-ESD</acronym>
  <official_title>Embryo Development Measure Depending on the DNA Sperm Fragmentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVI Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IVI Madrid</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The embryokinetics may be a new prognostic factor for choosing the human embryos with the&#xD;
      highest implantation potential. In order to identify the factors that may affect the rate of&#xD;
      embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen&#xD;
      tension, oocyte quality or type of medication used for ovarian stimulation. However there are&#xD;
      no published data with respect to the influence of sperm DNA fragmentation in the embryo&#xD;
      kinetic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Because we don´t have the necessary technology anymore&#xD;
  </why_stopped>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of pronuclear appearance in hours.</measure>
    <time_frame>The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups</time_frame>
    <description>We want to study whether differences exist in the time of appearance of pronuclei in those embryos that derived from semen samples from the two study groups&#xD;
the minimum value of the difference to be detected; we said that about 3 hours apart.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Blastocyst Time</condition>
  <condition>Pronuclear Appearance</condition>
  <condition>Pronuclear Fading</condition>
  <condition>Embryo Compaction</condition>
  <condition>Cleavage Times</condition>
  <arm_group>
    <arm_group_label>MACS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with MACS Selection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MACS</intervention_name>
    <arm_group_label>MACS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 36 to 38 years&#xD;
&#xD;
          -  Fresh sample semen&#xD;
&#xD;
          -  Minimum 6 oocytes&#xD;
&#xD;
          -  Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 36 or older than 38 years old&#xD;
&#xD;
          -  Frozen semen sample&#xD;
&#xD;
          -  Less tan 6 oocytes.&#xD;
&#xD;
          -  Semen samples with less than 5 million / ml or less than 30% of motile sperm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manuela Alonso</last_name>
    <role>Study Director</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Agudo, PhD</last_name>
    <role>Study Director</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Testillano</last_name>
    <role>Study Chair</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Pacheco, PhD</last_name>
    <role>Study Director</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IVI Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IVI Madrid</investigator_affiliation>
    <investigator_full_name>David Agudo Garcillan</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <!-- 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/NCT02214537
org study id: MADDA12201301
nct id: NCT02214537
lead sponsor: 
has dmc: Yes
The embryokinetics may be a new prognostic factor for choosing the human embryos with the
      highest implantation potential. In order to identify the factors that may affect the rate of
      embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen
      tension, oocyte quality or type of medication used for ovarian stimulation. However there are
      no published data with respect to the influence of sperm DNA fragmentation in the embryo
      kinetic.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Time of pronuclear appearance in hours.
time frame: The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups
description: We want to study whether differences exist in the time of appearance of pronuclei in those embryos that derived from semen samples from the two study groups
the minimum value of the difference to be detected; we said that about 3 hours apart.
arm group label: MACS
arm group type: Experimental
description: Patients with MACS Selection
intervention type: Other
intervention name: MACS
arm group label: MACS
criteria: 
gender: All
minimum age: 36 Years
maximum age: 38 Years
healthy volunteers: No
last name: Manuela Alonso
role: Study Director
affiliation: IVI Madrid
last name: David Agudo, PhD
role: Study Director
affiliation: IVI Madrid
last name: Maria Testillano
role: Study Chair
affiliation: IVI Madrid
last name: Alberto Pacheco, PhD
role: Study Director
affiliation: IVI Madrid
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: IVI Madrid
investigator full name: David Agudo Garcillan
investigator title: PHD