<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/NCT01723982</url>
  </required_header>
  <id_info>
    <org_study_id>000048</org_study_id>
    <secondary_id>2012-001622-10</secondary_id>
    <nct_id>NCT01723982</nct_id>
  </id_info>
  <brief_title>Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions</brief_title>
  <acronym>BASIC</acronym>
  <official_title>A Randomised, Placebo-controlled, Double-blind, Parallel Groups, Multinational, Multicentre Trial Assessing the Effect of Barusiban Administered Subcutaneously on the Day of Transfer on Implantation and Pregnancy Rates in IVF/ICSI Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial investigates the effects of FE 200440 compared to placebo on implantation rate in&#xD;
      women undergoing IVF/ICSI treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 2</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing implantation rate</measure>
    <time_frame>10-11 weeks after embryo transfer</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>10-11 weeks after transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>5-6 weeks after transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>5-6 weeks after transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Beta Human Chorionic Gonadotrophin (βhCG) rate</measure>
    <time_frame>13-15 days after transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum barusiban concentration at the expected tmax</measure>
    <time_frame>30 min after 2nd IMP administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and intensity of adverse events</measure>
    <time_frame>Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and intensity of injection site reactions</measure>
    <time_frame>Immediately and 30 min after each administration of IMP</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>A. FE 200440</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Barusiban (FE 200440) Solution for Injection for Subcutaneous use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B. Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Solution for Injection for Subcutaneous use</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Barusiban (FE 200440)</intervention_name>
    <arm_group_label>A. FE 200440</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <arm_group_label>B. Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-37 years&#xD;
&#xD;
          -  Women who have undergone 2-4 previous fresh in vitro fertilization (IVF) or&#xD;
             intracytoplasmatic sperm injection (ICSI) cycles that all resulted in a negative βhCG&#xD;
             test, despite transfer of at least one embryo/blastocyst of good quality&#xD;
&#xD;
          -  Women who have in the current controlled ovarian stimulation cycle for IVF/ICSI&#xD;
             followed the long Gonadotrophin Releasing Hormone (GnRH) agonist or GnRH antagonist&#xD;
             protocol, received hCG for triggering of final follicular maturation and have&#xD;
             undergone oocyte retrieval for IVF/ICSI with the purpose of fresh transfer&#xD;
&#xD;
          -  Retrieval of at least 6 oocytes in the current controlled ovarian stimulation cycle&#xD;
&#xD;
          -  Subjects should have at least one embryo of good quality available for transfer on day&#xD;
             3, or at least one good quality blastocyst available for transfer on day 5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A total of 6 or more controlled ovarian stimulation cycles for IVF/ICSI&#xD;
&#xD;
          -  Abnormal karyotype&#xD;
&#xD;
          -  Uterine pathology or hydrosalpinx&#xD;
&#xD;
          -  Diagnosed with acquired or congenital thrombophilia disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westmead Fertility Centre</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash IVF</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne IVF</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Jan Palfijn Gent AV</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique OVO</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICF CUBE</name>
      <address>
        <city>Prague</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>nOvum</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Alicante</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dexeus</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Madrid</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Sevilla</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>Poland</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>June 15, 2015</last_update_submitted>
  <last_update_submitted_qc>June 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT01723982
org study id: 000048
secondary id: 2012-001622-10
nct id: NCT01723982
lead sponsor: 
has dmc: No
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in
      women undergoing IVF/ICSI treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ongoing implantation rate
time frame: 10-11 weeks after embryo transfer
measure: Ongoing pregnancy rate
time frame: 10-11 weeks after transfer
measure: Implantation rate
time frame: 5-6 weeks after transfer
measure: Clinical pregnancy rate
time frame: 5-6 weeks after transfer
measure: Positive Beta Human Chorionic Gonadotrophin (βhCG) rate
time frame: 13-15 days after transfer
measure: Serum barusiban concentration at the expected tmax
time frame: 30 min after 2nd IMP administration
measure: Frequency and intensity of adverse events
time frame: Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer
measure: Frequency and intensity of injection site reactions
time frame: Immediately and 30 min after each administration of IMP
arm group label: A. FE 200440
arm group type: Experimental
description: Barusiban (FE 200440) Solution for Injection for Subcutaneous use
arm group label: B. Placebo
arm group type: Placebo Comparator
description: Placebo Solution for Injection for Subcutaneous use
intervention type: Drug
intervention name: Barusiban (FE 200440)
arm group label: A. FE 200440
intervention type: Drug
intervention name: Placebo Comparator
arm group label: B. Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 37 Years
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
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country: Australia
country: Belgium
country: Canada
country: Czech Republic
country: Poland
country: Spain
responsible party type: Sponsor
mesh term: Infertility