<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/NCT03042364</url>
  </required_header>
  <id_info>
    <org_study_id>Miacol-2017-3H</org_study_id>
    <nct_id>NCT03042364</nct_id>
  </id_info>
  <brief_title>Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching</brief_title>
  <official_title>Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the impact of endometrial scratching on endometrial secretion, when&#xD;
      correlated to pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">March 14, 2018</completion_date>
  <primary_completion_date type="Actual">March 14, 2018</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>
    <intervention_model_description>Randomized clinical trial</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cytokine profile of the uterine secretome after therapeutic endometrial scratching</measure>
    <time_frame>Within 12 months</time_frame>
    <description>The secretome is analyzed using a Multiplex analysis with 45 cytokines, chemokines and growth factors from ProcartaPlex Immunoassay Kit, Affymetrix, eBioscience. The samples are normalized for total protein content using a Nanodrop spectrophometer, and the protein composition is further determined by sodium dodecyl sulphate-polyacrylamide gel electropheresis (SDS-PAGE).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunoassay Kit:</measure>
    <time_frame>Within 12 months</time_frame>
    <description>BDNF, EGF, Eotaxin, FGF-2, GMCSF, GRO-alpha, HGF, IFN alpha, IFN gamma, IL-1RA, IL-1alpha, IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17-A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1 alpha, MIP-1 beta, NGF beta, RANTES, PDGF-BB, PÅIGF-1, SCF, SDF-1 alpha, TNF alpha, TNF beta, VEGF-A, VEGF-D</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endometrial scratching before standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pipelle de Cornier</intervention_name>
    <description>RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IVF or ICSI patients with ≥1 previous implantation failure, despite transfer of a top&#xD;
             quality embryo or blastocyst.&#xD;
&#xD;
          -  Antagonist treatment&#xD;
&#xD;
          -  FSH: 2-12 IU/L&#xD;
&#xD;
          -  BMI: 18-32&#xD;
&#xD;
          -  Regular menstrual cycle&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected intrauterine abnormalities Planned use of specialized media or AHA&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fertility Clinic,Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fertility Clinic, Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fertility Clinic Horsens Hospital</name>
      <address>
        <city>Horsens</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fertility Clinic, Skive Hospital</name>
      <address>
        <city>Skive</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 15, 2018</last_update_submitted>
  <last_update_submitted_qc>March 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03042364
org study id: Miacol-2017-3H
nct id: NCT03042364
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigates the impact of endometrial scratching on endometrial secretion, when
      correlated to pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Diagnostic
masking: None (Open Label)
measure: Cytokine profile of the uterine secretome after therapeutic endometrial scratching
time frame: Within 12 months
description: The secretome is analyzed using a Multiplex analysis with 45 cytokines, chemokines and growth factors from ProcartaPlex Immunoassay Kit, Affymetrix, eBioscience. The samples are normalized for total protein content using a Nanodrop spectrophometer, and the protein composition is further determined by sodium dodecyl sulphate-polyacrylamide gel electropheresis (SDS-PAGE).
measure: Immunoassay Kit:
time frame: Within 12 months
description: BDNF, EGF, Eotaxin, FGF-2, GMCSF, GRO-alpha, HGF, IFN alpha, IFN gamma, IL-1RA, IL-1alpha, IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17-A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1 alpha, MIP-1 beta, NGF beta, RANTES, PDGF-BB, PÅIGF-1, SCF, SDF-1 alpha, TNF alpha, TNF beta, VEGF-A, VEGF-D
arm group label: No intervention
arm group type: No Intervention
description: Standard treatment
arm group label: Intervention
arm group type: Experimental
description: Endometrial scratching before standard treatment
intervention type: Other
intervention name: Pipelle de Cornier
description: RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day
arm group label: Intervention
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: Undecided