<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/NCT03758885</url>
  </required_header>
  <id_info>
    <org_study_id>18-OBE001-010</org_study_id>
    <nct_id>NCT03758885</nct_id>
  </id_info>
  <brief_title>Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF</brief_title>
  <acronym>IMPLANT4</acronym>
  <official_title>A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ObsEva SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ObsEva SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose&#xD;
      of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks&#xD;
      post-embryo transfer (ET) day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, randomised, parallel group, double-blind, placebo-controlled,&#xD;
      Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase&#xD;
      pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer&#xD;
      following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 21, 2019</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing pregnancy with fetal heart beat at 10 weeks</measure>
    <time_frame>10 weeks post ET day</time_frame>
    <description>Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Live birth</measure>
    <time_frame>24 to 40 weeks of gestation</time_frame>
    <description>Live birth after 24 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy at 6 weeks post ET day</measure>
    <time_frame>6 weeks post ET</time_frame>
    <description>Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate at 14 days post Oocyte Pick-up (OPU)</measure>
    <time_frame>14 days post OPU</time_frame>
    <description>Positive blood pregnancy test at 14 days post OPU day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy loss</measure>
    <time_frame>6 weeks post ET to 24 weeks gestation</time_frame>
    <description>Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of nolasiban</measure>
    <time_frame>3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration</time_frame>
    <description>Plasma concentrations of nolasiban after administration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>Through study completion, up to 11 months</time_frame>
    <description>Treatment emergent adverse events frequency and severity</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal assessments</measure>
    <time_frame>Birth of infant until 28 days</time_frame>
    <description>Incidence of any malformation or any significant morbidity during the neonatal period</description>
  </other_outcome>
  <other_outcome>
    <measure>Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire</measure>
    <time_frame>6 and 12 months after term</time_frame>
    <description>Screening questionnaire composed of 30 questions completed by the parent. Questions are divided into five areas: communication, gross motor, fine motor, problem solving and personal-social. Parents respond yes, sometimes and not yet to questions, these are converted to points 10, 5 and 0 for scoring and are totalled for each developmental area. These 5 area scores are compared with empirically derived cutoff points.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">820</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Nolasiban 900 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nolasiban dispersible tablets for single oral administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo dispersible tablets for single oral administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nolasiban</intervention_name>
    <description>Nolasiban single oral administration</description>
    <arm_group_label>Nolasiban 900 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo single oral administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)&#xD;
&#xD;
          -  Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection&#xD;
             of human chorionic gonadotropin (hCG) for triggering final follicular maturation and&#xD;
             luteal support with vaginal micronized progesterone.&#xD;
&#xD;
          -  Single fresh D5 embryo transfer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Frozen-thawed embryo transfer&#xD;
&#xD;
          -  Donor egg in the current transfer&#xD;
&#xD;
          -  More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle&#xD;
&#xD;
          -  Serum P4 greater than 1.5 ng/mL prior to hCG administration&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Site 1001</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1003</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1004</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1002</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1404</name>
      <address>
        <city>Burnaby</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1401</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1402</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1403</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1107</name>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1101</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1102</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1103</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1104</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1105</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1108</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1110</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1109</name>
      <address>
        <city>Teplice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1106</name>
      <address>
        <city>Zlín</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1205</name>
      <address>
        <city>Herlev</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1202</name>
      <address>
        <city>Hvidovre</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1204</name>
      <address>
        <city>Kobenhavn</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1203</name>
      <address>
        <city>Skive</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1302</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1301</name>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1303</name>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1504</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1506</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1505</name>
      <address>
        <city>Bielefeld</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1501</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1502</name>
      <address>
        <city>Lubeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1503</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1601</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1603</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1602</name>
      <address>
        <city>Tapolca</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1703</name>
      <address>
        <city>Białystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1705</name>
      <address>
        <city>Białystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1702</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1701</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1704</name>
      <address>
        <city>Szczecin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1706</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1902</name>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1901</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1905</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1904</name>
      <address>
        <city>Samara</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1805</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1808</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1809</name>
      <address>
        <city>Leioa</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1804</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1807</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1811</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>ICSI</keyword>
  <keyword>ART</keyword>
  <keyword>ET</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/NCT03758885
org study id: 18-OBE001-010
nct id: NCT03758885
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose
      of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks
      post-embryo transfer (ET) day.
The study is a prospective, randomised, parallel group, double-blind, placebo-controlled,
      Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase
      pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer
      following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ongoing pregnancy with fetal heart beat at 10 weeks
time frame: 10 weeks post ET day
description: Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
measure: Live birth
time frame: 24 to 40 weeks of gestation
description: Live birth after 24 weeks of gestation
measure: Clinical pregnancy at 6 weeks post ET day
time frame: 6 weeks post ET
description: Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day
measure: Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
time frame: 14 days post OPU
description: Positive blood pregnancy test at 14 days post OPU day
measure: Pregnancy loss
time frame: 6 weeks post ET to 24 weeks gestation
description: Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation
measure: Plasma concentrations of nolasiban
time frame: 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration
description: Plasma concentrations of nolasiban after administration
measure: Adverse events
time frame: Through study completion, up to 11 months
description: Treatment emergent adverse events frequency and severity
measure: Neonatal assessments
time frame: Birth of infant until 28 days
description: Incidence of any malformation or any significant morbidity during the neonatal period
measure: Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire
time frame: 6 and 12 months after term
description: Screening questionnaire composed of 30 questions completed by the parent. Questions are divided into five areas: communication, gross motor, fine motor, problem solving and personal-social. Parents respond yes, sometimes and not yet to questions, these are converted to points 10, 5 and 0 for scoring and are totalled for each developmental area. These 5 area scores are compared with empirically derived cutoff points.
arm group label: Nolasiban 900 mg
arm group type: Experimental
description: Nolasiban dispersible tablets for single oral administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo dispersible tablets for single oral administration
intervention type: Drug
intervention name: Nolasiban
description: Nolasiban single oral administration
arm group label: Nolasiban 900 mg
intervention type: Drug
intervention name: Placebo
description: Placebo single oral administration
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 37 Years
healthy volunteers: No
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country: Belgium
country: Canada
country: Czechia
country: Denmark
country: Estonia
country: Germany
country: Hungary
country: Poland
country: Russian Federation
country: Spain
responsible party type: Sponsor
mesh term: Infertility