<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/NCT02246309</url>
  </required_header>
  <id_info>
    <org_study_id>ER08282014-01</org_study_id>
    <nct_id>NCT02246309</nct_id>
  </id_info>
  <brief_title>Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture</brief_title>
  <official_title>Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture at Center for Human Reproduction(CHR):an Open Label Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for Human Reproduction</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FertiliTech Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for Human Reproduction</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Embryoscopes,&quot; allow for embryo culture to be performed in an automated incubation system&#xD;
      under time lapse photography. Manufacturers of these systems (and investigators who have used&#xD;
      these systems) claim that the availability of 24-hour time-lapse photographic control&#xD;
      improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They&#xD;
      also claim that use of this system saves laboratory personnel time.&#xD;
&#xD;
      This study will randomize approximately 120 patients (60 in each arm) to standard embryo&#xD;
      culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time&#xD;
      spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A large number of IVF centers all around the world are converting from standard embryology&#xD;
      practice, where embryos are by embryologists manually processed during culture, to so-called&#xD;
      &quot;embryoscopes,&quot; where embryo culture is performed in an automated incubation system under&#xD;
      time lapse photography.&#xD;
&#xD;
      Manufacturers of these systems (and investigators who have used these systems) claim that the&#xD;
      availability of 24-hour time-lapse photographic control improves embryo selection and,&#xD;
      therefore, IVF pregnancy rates. They also claim that use of this system saves laboratory&#xD;
      personnel time. The FDA has so far, therefore, approved for sale at least 2 such systems In&#xD;
      the USA.&#xD;
&#xD;
      (i) Our analysis of the published literature has failed to find studies in support of the&#xD;
      claim that utilization of such equipment really improves pregnancy rates with IVF; and (ii)&#xD;
      Investigators are concerned that CHR's highly adversely selected patient population may&#xD;
      demonstrate different utilization outcomes from standard patient populations, especially&#xD;
      since this equipment is usually utilized to culture embryos to blastocyst stage (days 5/6),&#xD;
      while CHR cultures most patients only to day-3.&#xD;
&#xD;
      Investigators, therefore, contacted the manufacturer of the first FDA approved system, and&#xD;
      explained our concerns. The manufacturer agreed to loan us one of their systems for a&#xD;
      4-months long study free of charge (CHR just pays a nominal amount for installation and&#xD;
      training costs) but will be financially responsible for supplies.&#xD;
&#xD;
      During these 4 months, CHR will perform an open-label prospective (registered) and randomized&#xD;
      clinical trial, in which investigators, based on computerized randomization, will assign all&#xD;
      CHR patients (who agree to participate with informed written consent), either to standard&#xD;
      embryology or &quot;embryoscope&quot; embryology.&#xD;
&#xD;
      Recruiting approximately 30 patients per month into the study is anticipated, which would&#xD;
      give us a population of ~n=60 in each study group.&#xD;
&#xD;
      Patient with excessive numbers of eggs retrieved (&gt;12) will be excluded since the purpose of&#xD;
      this study is to investigate the utility of the system in a relatively adversely selected&#xD;
      patient population. All other patients will be offered participation.&#xD;
&#xD;
      The study will have as primary end point a time analysis of laboratory manpower, under which&#xD;
      the time spent on each patient by embryologist will be recorded and compared and as secondary&#xD;
      end point IVF cycle outcome, defined by number of good quality embryos available for&#xD;
      transfer, implantation rates and clinical pregnancy rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Equipment was loaned Lifglobal, Guilford, CT, USA and had to be returned.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Personnel Effort</measure>
    <time_frame>Three days</time_frame>
    <description>Number of minutes spent by laboratory personnel technical staff in support of each system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Embryo Quality</measure>
    <time_frame>Three Days</time_frame>
    <description>Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Pregnancy Rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Embryoscope Time Lapse System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Embryo Culture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embryoscope Time Lapse System</intervention_name>
    <description>The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.</description>
    <arm_group_label>Embryoscope Time Lapse System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Embryo Culture</intervention_name>
    <description>Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.</description>
    <arm_group_label>Standard Embryo Culture</arm_group_label>
    <other_name>Standard water jacketed incubator system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients already planning to undergo in vitro fertilization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with more than 12 oocytes will be excluded from this trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Barad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Human Reproduction</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Human Reproduction</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.</citation>
    <PMID>27553622</PMID>
  </results_reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>July 19, 2017</results_first_submitted>
  <results_first_submitted_qc>April 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2018</results_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infertility</keyword>
  <keyword>Embryo Culture</keyword>
  <keyword>Laboratory Technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was completed during 3.5 months between December 2014 and March 2015, the time period our center (Center for Human Reproduction in New York City).</recruitment_details>
      <pre_assignment_details>134 patients were offered participation during the study period. Ten were excluded because they were using embryo banking. Eighty five declined participation leaving only 49 qualified and/or consented to participate.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Embryoscope Time Lapse System</title>
          <description>All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.</description>
        </group>
        <group group_id="P2">
          <title>Standard Embryo Culture</title>
          <description>All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16">16 patients going through Time Lapse System and 15 through Standard Embryo Culture.</participants>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Embryoscope Time Lapse System</title>
          <description>All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.</description>
        </group>
        <group group_id="B2">
          <title>Standard Embryo Culture</title>
          <description>All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.8" spread="4"/>
                    <measurement group_id="B2" value="40.4" spread="6.97"/>
                    <measurement group_id="B3" value="39.5" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Personnel Effort</title>
        <description>Number of minutes spent by laboratory personnel technical staff in support of each system</description>
        <time_frame>Three days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Embryoscope Time Lapse System</title>
            <description>All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.</description>
          </group>
          <group group_id="O2">
            <title>Standard Embryo Culture</title>
            <description>All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.</description>
          </group>
        </group_list>
        <measure>
          <title>Personnel Effort</title>
          <description>Number of minutes spent by laboratory personnel technical staff in support of each system</description>
          <units>technical staff minutes spent per embryo</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>embryos</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>embryos</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="301.2" spread="80.8"/>
                    <measurement group_id="O2" value="137.6" spread="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Embryo Quality</title>
        <description>Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)</description>
        <time_frame>Three Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Embryoscope Time Lapse System</title>
            <description>All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.</description>
          </group>
          <group group_id="O2">
            <title>Standard Embryo Culture</title>
            <description>All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.</description>
          </group>
        </group_list>
        <measure>
          <title>Embryo Quality</title>
          <description>Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)</description>
          <units>Embryos</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.3"/>
                    <measurement group_id="O2" value="1.2" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinical Pregnancy Rate</title>
        <description>Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Embryoscope Time Lapse System</title>
            <description>All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.</description>
          </group>
          <group group_id="O2">
            <title>Standard Embryo Culture</title>
            <description>All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Pregnancy Rate</title>
          <description>Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One Month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Embryoscope Time Lapse System</title>
          <description>All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Embryoscope Time Lapse System: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.</description>
        </group>
        <group group_id="E2">
          <title>Standard Embryo Culture</title>
          <description>All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.&#xD;
Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. David Barad, Director of Clinical Research</name_or_title>
      <organization>Center for Human Reproduction</organization>
      <phone>2129944400 ext 212</phone>
      <email>dbarad@theCHR.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02246309
org study id: ER08282014-01
nct id: NCT02246309
lead sponsor: 
collaborator: 
has dmc: No
"Embryoscopes," allow for embryo culture to be performed in an automated incubation system
      under time lapse photography. Manufacturers of these systems (and investigators who have used
      these systems) claim that the availability of 24-hour time-lapse photographic control
      improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They
      also claim that use of this system saves laboratory personnel time.

      This study will randomize approximately 120 patients (60 in each arm) to standard embryo
      culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time
      spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.
A large number of IVF centers all around the world are converting from standard embryology
      practice, where embryos are by embryologists manually processed during culture, to so-called
      "embryoscopes," where embryo culture is performed in an automated incubation system under
      time lapse photography.

      Manufacturers of these systems (and investigators who have used these systems) claim that the
      availability of 24-hour time-lapse photographic control improves embryo selection and,
      therefore, IVF pregnancy rates. They also claim that use of this system saves laboratory
      personnel time. The FDA has so far, therefore, approved for sale at least 2 such systems In
      the USA.

      (i) Our analysis of the published literature has failed to find studies in support of the
      claim that utilization of such equipment really improves pregnancy rates with IVF; and (ii)
      Investigators are concerned that CHR's highly adversely selected patient population may
      demonstrate different utilization outcomes from standard patient populations, especially
      since this equipment is usually utilized to culture embryos to blastocyst stage (days 5/6),
      while CHR cultures most patients only to day-3.

      Investigators, therefore, contacted the manufacturer of the first FDA approved system, and
      explained our concerns. The manufacturer agreed to loan us one of their systems for a
      4-months long study free of charge (CHR just pays a nominal amount for installation and
      training costs) but will be financially responsible for supplies.

      During these 4 months, CHR will perform an open-label prospective (registered) and randomized
      clinical trial, in which investigators, based on computerized randomization, will assign all
      CHR patients (who agree to participate with informed written consent), either to standard
      embryology or "embryoscope" embryology.

      Recruiting approximately 30 patients per month into the study is anticipated, which would
      give us a population of ~n=60 in each study group.

      Patient with excessive numbers of eggs retrieved (>12) will be excluded since the purpose of
      this study is to investigate the utility of the system in a relatively adversely selected
      patient population. All other patients will be offered participation.

      The study will have as primary end point a time analysis of laboratory manpower, under which
      the time spent on each patient by embryologist will be recorded and compared and as secondary
      end point IVF cycle outcome, defined by number of good quality embryos available for
      transfer, implantation rates and clinical pregnancy rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Personnel Effort
time frame: Three days
description: Number of minutes spent by laboratory personnel technical staff in support of each system
measure: Embryo Quality
time frame: Three Days
description: Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)
measure: Clinical Pregnancy Rate
time frame: 4 weeks
description: Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer
arm group label: Embryoscope Time Lapse System
arm group type: Experimental
description: All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.
arm group label: Standard Embryo Culture
arm group type: Active Comparator
description: All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.
intervention type: Device
intervention name: Embryoscope Time Lapse System
description: The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.
arm group label: Embryoscope Time Lapse System
intervention type: Device
intervention name: Standard Embryo Culture
description: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
arm group label: Standard Embryo Culture
other name: Standard water jacketed incubator system
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Barad, MD
role: Principal Investigator
affiliation: Center for Human Reproduction
facility: 
country: United States
citation: Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.
PMID: 27553622
responsible party type: Sponsor
mesh term: Infertility
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 