<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/NCT03791931</url>
  </required_header>
  <id_info>
    <org_study_id>CMC 18-0087-CTIL</org_study_id>
    <nct_id>NCT03791931</nct_id>
  </id_info>
  <brief_title>Cleavage Pattern of Embryos and Oxidative Parameters</brief_title>
  <official_title>Is Abnormal Cleavage Pattern of Embryos Associated With Different Oxidative Parameters Compared With That of Normally Cleaving Embryos? A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carmel Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate prospectively whether embryos with abnormal cleaving pattern have different&#xD;
      oxidative parameters from normally cleaving embryos, and to analyze whether these parameters&#xD;
      have an association with demographic, laboratory and clinical parameters including treatment&#xD;
      outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate prospectively whether embryos with abnormal cleaving pattern have different&#xD;
      oxidative parameters from normally cleaving embryos, and to analyze whether these parameters&#xD;
      have an association with demographic, laboratory and clinical parameters including treatment&#xD;
      outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implantation rate</measure>
    <time_frame>1 year</time_frame>
    <description>Implantation rate (positive BHCG)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical pregnancy as defined by appearance of gestational sac on ultrasound</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oxidative stress measurement in cleavage state embryos</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>oxidative stress measurement</intervention_name>
    <description>oxidative stress measurement</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing IVF for the treatment of infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 or &gt;45 years old&#xD;
&#xD;
          -  Patients with no embryos with direct cleavage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zofnat Wiener, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carmel Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zofnat Wiener, MD</last_name>
    <phone>97248250335</phone>
    <email>wiener_zofnat@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zofnat Wiener, MD</last_name>
      <phone>97248250147</phone>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>February 2, 2020</last_update_submitted>
  <last_update_submitted_qc>February 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carmel Medical Center</investigator_affiliation>
    <investigator_full_name>Zofnat Wiener</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03791931
org study id: CMC 18-0087-CTIL
nct id: NCT03791931
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate prospectively whether embryos with abnormal cleaving pattern have different
      oxidative parameters from normally cleaving embryos, and to analyze whether these parameters
      have an association with demographic, laboratory and clinical parameters including treatment
      outcome.
To investigate prospectively whether embryos with abnormal cleaving pattern have different
      oxidative parameters from normally cleaving embryos, and to analyze whether these parameters
      have an association with demographic, laboratory and clinical parameters including treatment
      outcome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: implantation rate
time frame: 1 year
description: Implantation rate (positive BHCG)
measure: clinical pregnancy rate
time frame: 1 year
description: Clinical pregnancy as defined by appearance of gestational sac on ultrasound
arm group label: Patients
arm group type: Other
description: Oxidative stress measurement in cleavage state embryos
intervention type: Diagnostic Test
intervention name: oxidative stress measurement
description: oxidative stress measurement
arm group label: Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zofnat Wiener, MD
role: Principal Investigator
affiliation: Carmel Medical Center
last name: Zofnat Wiener, MD
phone: 97248250335
email: wiener_zofnat@clalit.org.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Carmel Medical Center
investigator full name: Zofnat Wiener
investigator title: Principal investigator
mesh term: Infertility
sharing ipd: No