<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/NCT02219425</url>
  </required_header>
  <id_info>
    <org_study_id>Miacol-2014-2H</org_study_id>
    <nct_id>NCT02219425</nct_id>
  </id_info>
  <brief_title>Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women</brief_title>
  <official_title>Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women</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>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the gene expression of the endometrium after an&#xD;
      endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day&#xD;
      LH+7.&#xD;
&#xD;
      Tissue is analysed and compared for changes in gene expression profile using Seq RNA&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gene Expression of the Endometrium after an endometrial biopsy</measure>
    <time_frame>1 month between each biopsy</time_frame>
    <description>An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7.&#xD;
Endometrial tissue is analysed for changes in gene expression profile of various chemokines and cytokines using RNA Sequencing technology</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>endometrial biopsy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endometrial biopsy</intervention_name>
    <arm_group_label>endometrial biopsy</arm_group_label>
    <other_name>Pipelle de Cornier</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fertile women&#xD;
&#xD;
          -  Age: 18-40 years&#xD;
&#xD;
          -  BMI: 18-32&#xD;
&#xD;
          -  Regular menstrual cycle&#xD;
&#xD;
          -  No use of hormonal contraceptives or IUD the last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in need of a interpreter&#xD;
&#xD;
          -  Suspected intrauterine abnormalities&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Axel Forman, MD, DMsc</last_name>
    <role>Study Director</role>
    <affiliation>Departement of Gynaecology and Obstetrics, Aarhus University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mia Steengaard Olesen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fertility Clinic Horsens Hospital, Aarhus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fertility Clinic Horsens Hospital</name>
      <address>
        <city>Horsens</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 11, 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>January 29, 2017</last_update_submitted>
  <last_update_submitted_qc>January 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infertility</keyword>
  <keyword>Endometrium</keyword>
  <keyword>Endometrial biopsy</keyword>
  <keyword>Gene expression</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/NCT02219425
org study id: Miacol-2014-2H
nct id: NCT02219425
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate the gene expression of the endometrium after an
      endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.
An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day
      LH+7.

      Tissue is analysed and compared for changes in gene expression profile using Seq RNA
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gene Expression of the Endometrium after an endometrial biopsy
time frame: 1 month between each biopsy
description: An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7.
Endometrial tissue is analysed for changes in gene expression profile of various chemokines and cytokines using RNA Sequencing technology
arm group label: endometrial biopsy
arm group type: Other
intervention type: Procedure
intervention name: endometrial biopsy
arm group label: endometrial biopsy
other name: Pipelle de Cornier
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Axel Forman, MD, DMsc
role: Study Director
affiliation: Departement of Gynaecology and Obstetrics, Aarhus University
last name: Mia Steengaard Olesen, MD
role: Principal Investigator
affiliation: Fertility Clinic Horsens Hospital, Aarhus University
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Infertility