<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/NCT01674894</url>
  </required_header>
  <id_info>
    <org_study_id>000063</org_study_id>
    <nct_id>NCT01674894</nct_id>
  </id_info>
  <brief_title>Study of the Cleavage of the Egg in Relation to the Stimulation Treatment</brief_title>
  <official_title>Kinetics in Time-lapse Culture of Human Preembryos</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 post-marketing, single-center prospective study will be conducted in an open-label,&#xD;
      non-interventional setting, for women seeking fertility treatment and will describe cleavage&#xD;
      dynamics in relation to the age of the oocyte and gonadotrophin treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 10, 2016</completion_date>
  <primary_completion_date type="Actual">December 10, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)</measure>
    <time_frame>Week 1 after oocyte retrieval</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time for disappearance of pronuclei in transferred embryos</measure>
    <time_frame>Week 1 after oocyte retrieval</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time for first cleavage in transferred embryos</measure>
    <time_frame>Week 1 after oocyte retrieval</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos</measure>
    <time_frame>Week 1 after oocyte retrieval</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage</measure>
    <time_frame>Week 1 after oocyte retrieval</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total dose of gonadotrophin used</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gonadotrophin dose per oocyte retrieved</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of oocytes retrieved</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of fertilized and cleaved oocytes</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of preembryos with top quality</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate week 7</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">356</enrollment>
  <condition>Female Infertility</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Women treated with Menopur</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Women treated with Menopur and Bravelle</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women suffering from infertility&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. IVF/ICSI treatment&#xD;
&#xD;
          2. Regular cycles of 25-35 days&#xD;
&#xD;
          3. Follicle stimulation with Bravelle and/or Menopur&#xD;
&#xD;
          4. Women aged 38-35 years&#xD;
&#xD;
          5. Long agonist or short antagonist treatment&#xD;
&#xD;
          6. Willing and able to understand a Danish, English or German patient information form&#xD;
&#xD;
          7. Willing and able to provide written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. BMI more than 35&#xD;
&#xD;
          2. Presence of hydrosalpinx on ultrasound&#xD;
&#xD;
          3. FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation&#xD;
&#xD;
          4. Known allergic reactions to the planned medications&#xD;
&#xD;
          5. Use of testicular sperm&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>38 Years</minimum_age>
    <maximum_age>45 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>Danish Fertility Clinic</name>
      <address>
        <city>Frederiksberg</city>
        <state>Copenhagen</state>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</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>
    <mesh_term>Infertility, Female</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/NCT01674894
org study id: 000063
nct id: NCT01674894
lead sponsor: 
has dmc: No
This post-marketing, single-center prospective study will be conducted in an open-label,
      non-interventional setting, for women seeking fertility treatment and will describe cleavage
      dynamics in relation to the age of the oocyte and gonadotrophin treatment.
observational model: Cohort
time perspective: Prospective
measure: Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)
time frame: Week 1 after oocyte retrieval
measure: Time for disappearance of pronuclei in transferred embryos
time frame: Week 1 after oocyte retrieval
measure: Time for first cleavage in transferred embryos
time frame: Week 1 after oocyte retrieval
measure: Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos
time frame: Week 1 after oocyte retrieval
measure: Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage
time frame: Week 1 after oocyte retrieval
measure: Total dose of gonadotrophin used
time frame: 1 month
measure: Gonadotrophin dose per oocyte retrieved
time frame: 1 month
measure: Number of oocytes retrieved
time frame: 1 month
measure: Number of fertilized and cleaved oocytes
time frame: 1 month
measure: Number of preembryos with top quality
time frame: 1 month
measure: Implantation rate
time frame: 2 months
measure: Ongoing pregnancy rate week 7
time frame: 3 months
measure: Live birth rate
time frame: 9 months
arm group label: Group 1
description: Women treated with Menopur
arm group label: Group 2
description: Women treated with Menopur and Bravelle
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 38 Years
maximum age: 45 Years
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female