<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/NCT03813745</url>
  </required_header>
  <id_info>
    <org_study_id>COCdenudation</org_study_id>
    <nct_id>NCT03813745</nct_id>
  </id_info>
  <brief_title>Timing of COC Denudation and Embryo Quality</brief_title>
  <official_title>Timing of COC Denudation and Embryo Quality: A Prospective Randomised Sibling-Oocyte Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acıbadem Atunizade Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acıbadem Atunizade Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The relation between the timing of COC denudation and oocyte /embryo quality is&#xD;
      controversial. The aim of this study is to examine whether timing of denudation of sibling&#xD;
      oocytes has any effect on embryo quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrieved sibling cumulus-oocyte complexes (COCs) will be randomly divided into two groups,&#xD;
      in the first group denudation will be in 30 minutes after oocyte retrieval, in second group&#xD;
      denudation will take place after 2 hours of incubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2019</start_date>
  <completion_date type="Anticipated">June 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of good quality cleavage embryos</measure>
    <time_frame>3 days after microinjection</time_frame>
    <description>Quality of embryos will be assessed morphologically on day 3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Embryo utilization rate</measure>
    <time_frame>1 week after microinjection</time_frame>
    <description>Embryo utilization rate is defined as the number of embryos utilized (transferred or cryopreserved) per number of 2PN zygotes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>16-18 hour after microinjection</time_frame>
    <description>Proportion of injected oocytes with 2PN the day after injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cleavage rate</measure>
    <time_frame>2 days after microinjection</time_frame>
    <description>Proportion of cleaved zygotes on day 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blastulation rate</measure>
    <time_frame>1 week after microinjection</time_frame>
    <description>Blastocyst rate per oocyte</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>early denudation</arm_group_label>
    <description>Cumulus-oocyte complexes will be denudated in 30 min after oocyte retrieval</description>
  </arm_group>
  <arm_group>
    <arm_group_label>late denudation</arm_group_label>
    <description>Denudation will be done 2 hr after oocyte retrieval</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>early denudation</intervention_name>
    <description>COCs will be denudated in 30 min after oocyte retrieval</description>
    <arm_group_label>early denudation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>late denudation</intervention_name>
    <description>COCs will be denudated 2 hr after oocyte retrieval</description>
    <arm_group_label>late denudation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Those infertile patients eligible for the study design who are planned to be treated with&#xD;
        microinjection and has given written informed consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COH with GnRH antagonist cycle&#xD;
&#xD;
          -  5 or more oocytes collected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fewer than 4 oocytes after retrieval&#xD;
&#xD;
          -  Previous history of total fertilization failure or oocyte maturation arrest&#xD;
&#xD;
          -  Male partner requiring surgical sperm retrieval (MESA or TESA).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Acibadem Altunizade Hospitai</name>
      <address>
        <city>Istanbul</city>
        <zip>34785</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Esra Uyar</last_name>
      <phone>2164946526</phone>
      <email>dresrauyar@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>December 12, 2019</last_update_submitted>
  <last_update_submitted_qc>December 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acıbadem Atunizade Hospital</investigator_affiliation>
    <investigator_full_name>Elif Esra Uyar</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>embryo quality</keyword>
  <keyword>denudation</keyword>
  <keyword>IVF</keyword>
  <keyword>ICSI</keyword>
  <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/NCT03813745
org study id: COCdenudation
nct id: NCT03813745
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The relation between the timing of COC denudation and oocyte /embryo quality is
      controversial. The aim of this study is to examine whether timing of denudation of sibling
      oocytes has any effect on embryo quality.
Retrieved sibling cumulus-oocyte complexes (COCs) will be randomly divided into two groups,
      in the first group denudation will be in 30 minutes after oocyte retrieval, in second group
      denudation will take place after 2 hours of incubation.
observational model: Case-Control
time perspective: Prospective
measure: Number of good quality cleavage embryos
time frame: 3 days after microinjection
description: Quality of embryos will be assessed morphologically on day 3
measure: Embryo utilization rate
time frame: 1 week after microinjection
description: Embryo utilization rate is defined as the number of embryos utilized (transferred or cryopreserved) per number of 2PN zygotes.
measure: Fertilization rate
time frame: 16-18 hour after microinjection
description: Proportion of injected oocytes with 2PN the day after injection
measure: Cleavage rate
time frame: 2 days after microinjection
description: Proportion of cleaved zygotes on day 2
measure: Blastulation rate
time frame: 1 week after microinjection
description: Blastocyst rate per oocyte
arm group label: early denudation
description: Cumulus-oocyte complexes will be denudated in 30 min after oocyte retrieval
arm group label: late denudation
description: Denudation will be done 2 hr after oocyte retrieval
intervention type: Other
intervention name: early denudation
description: COCs will be denudated in 30 min after oocyte retrieval
arm group label: early denudation
intervention type: Other
intervention name: late denudation
description: COCs will be denudated 2 hr after oocyte retrieval
arm group label: late denudation
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Acıbadem Atunizade Hospital
investigator full name: Elif Esra Uyar
investigator title: Medical Doctor
mesh term: Infertility
mesh term: Infertility, Female