<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/NCT04485806</url>
  </required_header>
  <id_info>
    <org_study_id>MH0002</org_study_id>
    <nct_id>NCT04485806</nct_id>
  </id_info>
  <brief_title>Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.</brief_title>
  <official_title>The Effect of Culture Media Microdroplet Geometry and Different Oil Overlay on Pre Implantation Embryonic Development in Dry Incubators: Prospective Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ganin Fertility Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ganin Fertility Center</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>
      A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients&#xD;
      undergoing ICSI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      to determine the effect of culture media microdroplet geometry of different culture dishes&#xD;
      and oil overlay on the pre implantation embryo development in dry incubators&#xD;
&#xD;
      Method:&#xD;
&#xD;
      We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL&#xD;
      (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and&#xD;
      paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same&#xD;
      conditions.&#xD;
&#xD;
      statistical analysis done using SPSS version 23&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>
    <intervention_model_description>Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blastulation rate</measure>
    <time_frame>5-6 days after ICSI</time_frame>
    <description>Percentage of total blastocysts / Total cleaved embryos</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High quality blast rate</measure>
    <time_frame>5-6 days after ICSI</time_frame>
    <description>Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>16-19 hours of ICSI</time_frame>
    <description>Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cleavage rate</measure>
    <time_frame>72 hours of ICSI</time_frame>
    <description>Percentage of cleaved embryos/ total number of fertilized oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High quality D3 embryos</measure>
    <time_frame>72 hours of ICSI</time_frame>
    <description>High quality D3 embryos according to Gardner's criteria / total cleaved embryos</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Good quality trophectoderm/inner cell mass</measure>
    <time_frame>5-6 days after ICSI</time_frame>
    <description>better grade than 3BB of blast embryos according to Gardner's criteria 1999</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Embryonic Development</condition>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>GPS / LM versus SPL/LM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GPS/PO versus SPL/PO</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GPS/PO versus GPS/LM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPL/PO versus SPL/LM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GPS/LM</intervention_name>
    <description>Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay</description>
    <arm_group_label>GPS / LM versus SPL/LM</arm_group_label>
    <arm_group_label>GPS/PO versus GPS/LM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SPL/LM</intervention_name>
    <description>Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay</description>
    <arm_group_label>GPS / LM versus SPL/LM</arm_group_label>
    <arm_group_label>SPL/PO versus SPL/LM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GPS/PO</intervention_name>
    <description>Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay</description>
    <arm_group_label>GPS/PO versus GPS/LM</arm_group_label>
    <arm_group_label>GPS/PO versus SPL/PO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SPL/PO</intervention_name>
    <description>Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay</description>
    <arm_group_label>GPS/PO versus SPL/PO</arm_group_label>
    <arm_group_label>SPL/PO versus SPL/LM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female age is ≤ 37 years old with ≥ 8 MII oocytes&#xD;
&#xD;
          -  Males with normal semen parameters (WHO 2010).&#xD;
&#xD;
          -  We conducted three experiments all with Siblings oocytes splits and all embryos&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oocyte or sperm donation.&#xD;
&#xD;
          -  Sever male factor.&#xD;
&#xD;
          -  Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.&#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>Manar M Hozyen, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amr Elshimy, BSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanaa Elkhader, BSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam Zaki, MSc.</last_name>
    <role>Study Chair</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ganin Fertility Center</name>
      <address>
        <city>Cairo</city>
        <zip>11728</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dry incubator</keyword>
  <keyword>Osmolality</keyword>
  <keyword>Oil overlay</keyword>
  <keyword>Microdrops</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/NCT04485806
org study id: MH0002
nct id: NCT04485806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients
      undergoing ICSI.
Purpose:

      to determine the effect of culture media microdroplet geometry of different culture dishes
      and oil overlay on the pre implantation embryo development in dry incubators

      Method:

      We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL
      (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and
      paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same
      conditions.

      statistical analysis done using SPSS version 23
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.
primary purpose: Other
masking: None (Open Label)
measure: Blastulation rate
time frame: 5-6 days after ICSI
description: Percentage of total blastocysts / Total cleaved embryos
measure: High quality blast rate
time frame: 5-6 days after ICSI
description: Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.
measure: Fertilization rate
time frame: 16-19 hours of ICSI
description: Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
measure: Cleavage rate
time frame: 72 hours of ICSI
description: Percentage of cleaved embryos/ total number of fertilized oocytes
measure: High quality D3 embryos
time frame: 72 hours of ICSI
description: High quality D3 embryos according to Gardner's criteria / total cleaved embryos
measure: Good quality trophectoderm/inner cell mass
time frame: 5-6 days after ICSI
description: better grade than 3BB of blast embryos according to Gardner's criteria 1999
arm group label: GPS / LM versus SPL/LM
arm group type: Other
description: to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM).
arm group label: GPS/PO versus SPL/PO
arm group type: Other
description: to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO).
arm group label: GPS/PO versus GPS/LM
arm group type: Other
description: to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS).
arm group label: SPL/PO versus SPL/LM
arm group type: Other
description: to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL).
intervention type: Other
intervention name: GPS/LM
description: Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay
arm group label: GPS / LM versus SPL/LM
arm group label: GPS/PO versus GPS/LM
intervention type: Other
intervention name: SPL/LM
description: Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay
arm group label: GPS / LM versus SPL/LM
arm group label: SPL/PO versus SPL/LM
intervention type: Other
intervention name: GPS/PO
description: Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay
arm group label: GPS/PO versus GPS/LM
arm group label: GPS/PO versus SPL/PO
intervention type: Other
intervention name: SPL/PO
description: Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay
arm group label: GPS/PO versus SPL/PO
arm group label: SPL/PO versus SPL/LM
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 37 Years
healthy volunteers: No
last name: Manar M Hozyen, MSc.
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Amr Elshimy, BSc.
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hanaa Elkhader, BSc.
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hosam Zaki, MSc.
role: Study Chair
affiliation: Ganin Fertility Center
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Infertility