<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/NCT04485910</url>
  </required_header>
  <id_info>
    <org_study_id>MH0004</org_study_id>
    <nct_id>NCT04485910</nct_id>
  </id_info>
  <brief_title>PGTai Results for Embryos Cultured in Sequential Versus Single Step Media</brief_title>
  <official_title>Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program</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 cohort study undergoing ICSI at a private fertility center in Egypt&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      To evaluate PGTai results for embryos cultured in sequential versus single step media.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10%&#xD;
      SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage&#xD;
      and blastocyst media with 10% SPS (SAGE, Denmark).&#xD;
&#xD;
      All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go&#xD;
      through PGTA procedures with PGTai confirmation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Euploidy rate</measure>
    <time_frame>5:7 days of intracytoplasmic sperm injection(ICSI)</time_frame>
    <description>percentage of euploid embryos/ total genetic tested embryos on blast stage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mosaicism rate</measure>
    <time_frame>5:7 days of ICSI</time_frame>
    <description>percentage of mosaic embryos/ total genetic tested embryos on blast stage</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 stage</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 of cleaved 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>Blast formation rate</measure>
    <time_frame>5:7 days of ICSI</time_frame>
    <description>Percentage of total blastocysts / Total cleaved embryos</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High quality blast rate</measure>
    <time_frame>5:7 days of 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>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Infertility</condition>
  <condition>Aneuploidy Rate</condition>
  <condition>Mosaicism</condition>
  <arm_group>
    <arm_group_label>Single step media</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Embryos cultured in single step media</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential media</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Embryos cultured in sequential media</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single step media</intervention_name>
    <description>Usage of single step media in embryo culture</description>
    <arm_group_label>Single step media</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sequential media</intervention_name>
    <description>Usage of sequential media in embryo culture</description>
    <arm_group_label>Sequential media</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female age ≤37 years with ≥ 8 mature oocytes&#xD;
&#xD;
          -  Male partner had normal semen parameters according to WHO 2010&#xD;
&#xD;
          -  PGT-A was done at the blastocyst stage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sperm or oocyte donor&#xD;
&#xD;
          -  severe male factors according to WHO 2010&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female age ≤37 years with ≥ 8 mature oocytes</gender_description>
    <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>
  <overall_contact>
    <last_name>Manar M Hozyen, MSc.</last_name>
    <phone>+201229483320</phone>
    <email>manarnrc@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amr Elshimy, BSc.</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ganin Fertility Center</name>
      <address>
        <city>Cairo</city>
        <zip>11728</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 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>PGT-A</keyword>
  <keyword>Mosaicism</keyword>
  <keyword>Single step media</keyword>
  <keyword>Sequential media</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Aneuploidy</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/NCT04485910
org study id: MH0004
nct id: NCT04485910
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective cohort study undergoing ICSI at a private fertility center in Egypt
Purpose:

      To evaluate PGTai results for embryos cultured in sequential versus single step media.

      Method:

      Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10%
      SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage
      and blastocyst media with 10% SPS (SAGE, Denmark).

      All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go
      through PGTA procedures with PGTai confirmation.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
primary purpose: Other
masking: None (Open Label)
measure: Euploidy rate
time frame: 5:7 days of intracytoplasmic sperm injection(ICSI)
description: percentage of euploid embryos/ total genetic tested embryos on blast stage
measure: Mosaicism rate
time frame: 5:7 days of ICSI
description: percentage of mosaic embryos/ total genetic tested embryos on blast stage
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 stage
time frame: 72 hours of ICSI
description: Percentage of cleaved embryos/ total number of fertilized oocytes
measure: High quality of cleaved embryos
time frame: 72 hours of ICSI
description: High quality D3 embryos according to Gardner's criteria / total cleaved embryos
measure: Blast formation rate
time frame: 5:7 days of ICSI
description: Percentage of total blastocysts / Total cleaved embryos
measure: High quality blast rate
time frame: 5:7 days of 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.
arm group label: Single step media
arm group type: Active Comparator
description: Embryos cultured in single step media
arm group label: Sequential media
arm group type: Active Comparator
description: Embryos cultured in sequential media
intervention type: Other
intervention name: Single step media
description: Usage of single step media in embryo culture
arm group label: Single step media
intervention type: Other
intervention name: Sequential media
description: Usage of sequential media in embryo culture
arm group label: Sequential media
criteria: 
gender: All
gender based: Yes
gender description: Female age ≤37 years with ≥ 8 mature oocytes
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
last name: Manar M Hozyen, MSc.
phone: +201229483320
email: manarnrc@gmail.com
last name: Amr Elshimy, BSc.
facility: 
status: Recruiting
country: Egypt
responsible party type: Sponsor
mesh term: Infertility
mesh term: Aneuploidy