<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/NCT01673399</url>
  </required_header>
  <id_info>
    <org_study_id>2012-000278-49</org_study_id>
    <nct_id>NCT01673399</nct_id>
  </id_info>
  <brief_title>Oxytocin Antagonist in Patients With Repeated Failure of Implantation</brief_title>
  <official_title>Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AZ Jan Palfijn Gent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AZ Jan Palfijn Gent</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators compare the usual way of embryo transfer (without medication)&#xD;
      with an embryo transfer while administering oxytocine antagonist. This to improve&#xD;
      implantation and increase the pregnancy rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implantation rate</measure>
    <time_frame>16 days from eggretrieval</time_frame>
    <description>the number of patients that show a positive serum blood pregnancy test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pregnancy rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of patients with an ongoing first trimester pregnancy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Implantation Failure</condition>
  <arm_group>
    <arm_group_label>Atosiban</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive a bolus injection of 6.75mg atosiban and following an atosibaninfusion at 18mg/u during 3 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive a placebo bolus injection (NaCl 0.9%)and an infusion of NaCl 0.9% during 3 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atosiban</intervention_name>
    <description>Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.</description>
    <arm_group_label>Atosiban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IVF/ ICSI patients below 38 years&#xD;
&#xD;
          -  2e to 6e IVF-cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with endocrinological diseases or problems&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AZ Jan Palfijn</name>
      <address>
        <city>Gent</city>
        <state>Oost-vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AZ Jan Palfijn Gent</investigator_affiliation>
    <investigator_full_name>Dr. Decleer Wim</investigator_full_name>
    <investigator_title>gynecologist</investigator_title>
  </responsible_party>
  <keyword>repeated implantation failure (RIF)</keyword>
  <keyword>atosiban</keyword>
  <keyword>pregnancy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atosiban</mesh_term>
  </intervention_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/NCT01673399
org study id: 2012-000278-49
nct id: NCT01673399
lead sponsor: 
collaborator: 
has dmc: Yes
In this study the investigators compare the usual way of embryo transfer (without medication)
      with an embryo transfer while administering oxytocine antagonist. This to improve
      implantation and increase the pregnancy rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: implantation rate
time frame: 16 days from eggretrieval
description: the number of patients that show a positive serum blood pregnancy test
measure: pregnancy rate
time frame: 12 weeks
description: The number of patients with an ongoing first trimester pregnancy
arm group label: Atosiban
arm group type: Active Comparator
description: Patients receive a bolus injection of 6.75mg atosiban and following an atosibaninfusion at 18mg/u during 3 hours.
arm group label: placebo
arm group type: Placebo Comparator
description: Patients receive a placebo bolus injection (NaCl 0.9%)and an infusion of NaCl 0.9% during 3 hours
intervention type: Drug
intervention name: Atosiban
description: Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.
arm group label: Atosiban
intervention type: Drug
intervention name: placebo
arm group label: placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: AZ Jan Palfijn Gent
investigator full name: Dr. Decleer Wim
investigator title: gynecologist
mesh term: Atosiban