<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/NCT02218255</url>
  </required_header>
  <id_info>
    <org_study_id>2013-AUX-010</org_study_id>
    <nct_id>NCT02218255</nct_id>
  </id_info>
  <brief_title>Eeva™ Pregnancy Pilot Study (PPS)</brief_title>
  <acronym>PPS</acronym>
  <official_title>Eeva™ Pregnancy Pilot Study (PPS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Progyny, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Progyny, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical investigation is to gather pilot data to evaluate the impact of&#xD;
      using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on&#xD;
      clinical pregnancy rates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Pregnancy</measure>
    <time_frame>7-8 weeks gestation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>8-12 week gestation</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Day 3 eSET combined with Eeva</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional Morphology + Eeva™ results</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 5 eSET combined with Eeva</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional Morphology + Eeva™ results</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 5 eSET with Traditonal Morphology</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eeva™ results</intervention_name>
    <arm_group_label>Day 3 eSET combined with Eeva</arm_group_label>
    <arm_group_label>Day 5 eSET combined with Eeva</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing fresh in vitro fertilization treatment using their own eggs&#xD;
&#xD;
          -  ≤ 40 years&#xD;
&#xD;
          -  ≥ 4 diploid embryos (i.e. having 2 PNs)&#xD;
&#xD;
          -  ≤ 3 Prior ART cycles (IVF, ICSI and related procedures)&#xD;
&#xD;
          -  All 2PN embryos (for all 3 arms) must be imaged by Eeva&#xD;
&#xD;
          -  Subject willing to comply with study protocol and procedures&#xD;
&#xD;
          -  Subject willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preimplantation genetic diagnosis or preimplantation genetic screening&#xD;
&#xD;
          -  Planned &quot;freeze all&quot; cycle (eggs or embryos)&#xD;
&#xD;
          -  Asherman's Syndrome&#xD;
&#xD;
          -  Donor egg&#xD;
&#xD;
          -  Gestational carrier&#xD;
&#xD;
          -  Presence of Hydrosalpinx on ultrasound&#xD;
&#xD;
          -  Concurrent participation in an interventional clinical study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Monica Ransom</last_name>
    <phone>650-627-7604</phone>
    <email>mransom@auxogyn.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Racowsky, Ph.D.</last_name>
      <phone>617-732-5570</phone>
      <email>cracowsky@partners.org</email>
    </contact>
    <investigator>
      <last_name>Catherine Racowsky, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>In Vitro Fertilization</keyword>
  <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/NCT02218255
org study id: 2013-AUX-010
nct id: NCT02218255
lead sponsor: 
has dmc: No
The purpose of this clinical investigation is to gather pilot data to evaluate the impact of
      using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on
      clinical pregnancy rates.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical Pregnancy
time frame: 7-8 weeks gestation
measure: Ongoing pregnancy rate
time frame: 8-12 week gestation
arm group label: Day 3 eSET combined with Eeva
arm group type: Active Comparator
description: Traditional Morphology + Eeva™ results
arm group label: Day 5 eSET combined with Eeva
arm group type: Active Comparator
description: Traditional Morphology + Eeva™ results
arm group label: Day 5 eSET with Traditonal Morphology
arm group type: No Intervention
intervention type: Device
intervention name: Eeva™ results
arm group label: Day 3 eSET combined with Eeva
arm group label: Day 5 eSET combined with Eeva
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Monica Ransom
phone: 650-627-7604
email: mransom@auxogyn.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Infertility