<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/NCT02222831</url>
  </required_header>
  <id_info>
    <org_study_id>Skive-2014-BBP</org_study_id>
    <nct_id>NCT02222831</nct_id>
  </id_info>
  <brief_title>Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.</brief_title>
  <official_title>Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regionshospitalet Viborg, Skive</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regionshospitalet Viborg, Skive</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study are to evaluate:&#xD;
&#xD;
        1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on&#xD;
           fertilisation rates and embryo quality in standard IVF.&#xD;
&#xD;
        2. the association between PIF status in embryo culture medium and embryo quality assessed&#xD;
           by standard subjective parameters and morphokinetic development.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Embryo Quality</measure>
    <time_frame>Day 0-5 after oocyte pick-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fertilisation rate</measure>
    <time_frame>Day 1 after oocyte pick-up</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>7th week of gestation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>In Vitro Fertilization</condition>
  <condition>Assisted Reproductive Techniques</condition>
  <arm_group>
    <arm_group_label>Day 0 - Study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 0 denudation and time lapse culture on IVF-oocytes.:&#xD;
After insemination the oocytes will subsequently be denuded and cultured in the EmbryoScope (day 0).&#xD;
The embryo culture media will be collected at day 2-5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 1 - control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After insemination oocytes in the control group will be incubated in a standard incubator overnight. On day 1 the oocytes in the will be denuded and further cultured in the EmbryoScope.&#xD;
The embryo culture media will be collected at day 2-5.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Day 0 denudation and time lapse culture on IVF-oocytes.</intervention_name>
    <arm_group_label>Day 0 - Study arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Standard IVF treatment&#xD;
&#xD;
          -  Body mass Index (BMI) between 18 and 30&#xD;
&#xD;
          -  couples in which the male partner has normal sperm concentration and motility&#xD;
             according to the World Health Organization (WHO, 2010)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients with less than four oocytes&#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>Betina B Povlsen, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Fertility Clinic, Skive Regional Hospital, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Fertility Clinic Skive</name>
      <address>
        <city>Skive</city>
        <zip>7800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Regionshospitalet Viborg, Skive</investigator_affiliation>
    <investigator_full_name>Betina Boel Povlsen, MSc</investigator_full_name>
    <investigator_title>MSc, Laboratory Director, The Fertility Clinic Skive; Denmark.</investigator_title>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>Embryo Quality</keyword>
  <keyword>Time Lapse Culture</keyword>
  <keyword>Preimplantation factor</keyword>
  <!-- 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/NCT02222831
org study id: Skive-2014-BBP
nct id: NCT02222831
lead sponsor: 
has dmc: No
The aims of this study are to evaluate:

        1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on
           fertilisation rates and embryo quality in standard IVF.

        2. the association between PIF status in embryo culture medium and embryo quality assessed
           by standard subjective parameters and morphokinetic development.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Embryo Quality
time frame: Day 0-5 after oocyte pick-up
measure: Fertilisation rate
time frame: Day 1 after oocyte pick-up
measure: Clinical pregnancy rate
time frame: 7th week of gestation
arm group label: Day 0 - Study arm
arm group type: Experimental
description: Day 0 denudation and time lapse culture on IVF-oocytes.:
After insemination the oocytes will subsequently be denuded and cultured in the EmbryoScope (day 0).
The embryo culture media will be collected at day 2-5.
arm group label: Day 1 - control arm
arm group type: No Intervention
description: After insemination oocytes in the control group will be incubated in a standard incubator overnight. On day 1 the oocytes in the will be denuded and further cultured in the EmbryoScope.
The embryo culture media will be collected at day 2-5.
intervention type: Procedure
intervention name: Day 0 denudation and time lapse culture on IVF-oocytes.
arm group label: Day 0 - Study arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Betina B Povlsen, MSc
role: Principal Investigator
affiliation: The Fertility Clinic, Skive Regional Hospital, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Regionshospitalet Viborg, Skive
investigator full name: Betina Boel Povlsen, MSc
investigator title: MSc, Laboratory Director, The Fertility Clinic Skive; Denmark.