<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/NCT02189369</url>
  </required_header>
  <id_info>
    <org_study_id>1311-FIVI-135-CS</org_study_id>
    <nct_id>NCT02189369</nct_id>
  </id_info>
  <brief_title>Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer</brief_title>
  <official_title>Clinical Validation of a Diagnostic Test Which Measures the Endometrial Prostaglandins Liquid 24 Hours Before Embryo Transfer and That is Capable of Predicting a State of Endometrial Receptivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Igenomix</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Igenomix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical validation study is being carried out to validate the efficacy of a test&#xD;
      measuring the clinical application of prostaglandins present in the endometrial fluid in&#xD;
      patients, 24 hours before the embryonic transfer. This test is capable of predicting&#xD;
      endometrial receptivity without the need of performing a biopsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>endometrial receptivity</measure>
    <time_frame>24 hours before embryo transfer</time_frame>
    <description>The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>15 days</time_frame>
    <description>We will reffer a correlation between the prostaglandin results and the implantation rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>15 days</time_frame>
    <description>We will reffer a correlation between the prostaglandin results and the implantation rate.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Day 3 embryo-Own-above cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 5 embryo-Own-above cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 3 embryo-Donor-above cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 5 embryo-Donor- above cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 3 embryo-Donor-lower cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 5 embryo-Donor-lower cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 3 embryo-own-lower cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 5 embryo-own-lower cutoff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Day 3 embryo transfer</intervention_name>
    <description>Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer</description>
    <arm_group_label>Day 3 embryo-Donor-above cutoff</arm_group_label>
    <arm_group_label>Day 3 embryo-Donor-lower cutoff</arm_group_label>
    <arm_group_label>Day 3 embryo-Own-above cutoff</arm_group_label>
    <arm_group_label>Day 3 embryo-own-lower cutoff</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Day 5 embryo transfer</intervention_name>
    <description>Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer</description>
    <arm_group_label>Day 5 embryo-Donor- above cutoff</arm_group_label>
    <arm_group_label>Day 5 embryo-Donor-lower cutoff</arm_group_label>
    <arm_group_label>Day 5 embryo-Own-above cutoff</arm_group_label>
    <arm_group_label>Day 5 embryo-own-lower cutoff</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any IVF patient being treated for single or double embryo transfer&#xD;
&#xD;
          -  BMI: 20 - 30&#xD;
&#xD;
          -  Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral&#xD;
             Follicle Count)&#xD;
&#xD;
          -  Elective embryo transfer&#xD;
&#xD;
          -  Normal uterine cavity&#xD;
&#xD;
          -  Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with&#xD;
             donated oocytes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical&#xD;
             miscarriage)&#xD;
&#xD;
          -  Patients with severe male factor ( ≥ 2*106 espermatozoides/ml).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Simon, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación IVI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carlos Gómez, MA</last_name>
    <phone>+34670506469</phone>
    <email>carlos.gomez@igenomix.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fundación IVI</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlos Gómez, Ma</last_name>
      <phone>+34670506469</phone>
      <email>carlos.gomez@igenomix.com</email>
    </contact>
    <investigator>
      <last_name>Carlos Simón, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Felip Vilella, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IVI Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlos Gómez, MA</last_name>
      <email>carlos.gomez@igenomix.com</email>
    </contact>
    <investigator>
      <last_name>Carlos Simón, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcos Meseguer, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sergio Cabanillas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>March 6, 2017</last_update_submitted>
  <last_update_submitted_qc>March 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Igenomix</investigator_affiliation>
    <investigator_full_name>Carlos Simon</investigator_full_name>
    <investigator_title>Dr. Carlos Simón</investigator_title>
  </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/NCT02189369
org study id: 1311-FIVI-135-CS
nct id: NCT02189369
lead sponsor: 
has dmc: No
This clinical validation study is being carried out to validate the efficacy of a test
      measuring the clinical application of prostaglandins present in the endometrial fluid in
      patients, 24 hours before the embryonic transfer. This test is capable of predicting
      endometrial receptivity without the need of performing a biopsy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: endometrial receptivity
time frame: 24 hours before embryo transfer
description: The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.
measure: Implantation rate
time frame: 15 days
description: We will reffer a correlation between the prostaglandin results and the implantation rate.
measure: Pregnancy rate
time frame: 15 days
description: We will reffer a correlation between the prostaglandin results and the implantation rate.
arm group label: Day 3 embryo-Own-above cutoff
arm group type: Experimental
description: Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
arm group label: Day 5 embryo-Own-above cutoff
arm group type: Experimental
description: Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
arm group label: Day 3 embryo-Donor-above cutoff
arm group type: Experimental
description: Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
arm group label: Day 5 embryo-Donor- above cutoff
arm group type: Experimental
description: Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
arm group label: Day 3 embryo-Donor-lower cutoff
arm group type: Experimental
description: Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
arm group label: Day 5 embryo-Donor-lower cutoff
arm group type: Experimental
description: Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
arm group label: Day 3 embryo-own-lower cutoff
arm group type: Experimental
description: Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
arm group label: Day 5 embryo-own-lower cutoff
arm group type: Experimental
description: Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
intervention type: Other
intervention name: Day 3 embryo transfer
description: Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
arm group label: Day 3 embryo-Donor-above cutoff
arm group label: Day 3 embryo-Donor-lower cutoff
arm group label: Day 3 embryo-Own-above cutoff
arm group label: Day 3 embryo-own-lower cutoff
intervention type: Other
intervention name: Day 5 embryo transfer
description: Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer
arm group label: Day 5 embryo-Donor- above cutoff
arm group label: Day 5 embryo-Donor-lower cutoff
arm group label: Day 5 embryo-Own-above cutoff
arm group label: Day 5 embryo-own-lower cutoff
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Carlos Simon, MD PhD
role: Principal Investigator
affiliation: Fundación IVI
last name: Carlos Gómez, MA
phone: +34670506469
email: carlos.gomez@igenomix.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Igenomix
investigator full name: Carlos Simon
investigator title: Dr. Carlos Simón
mesh term: Infertility