<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/NCT02976662</url>
  </required_header>
  <id_info>
    <org_study_id>006735</org_study_id>
    <nct_id>NCT02976662</nct_id>
  </id_info>
  <brief_title>Artificial Shrinkage for Human Blastocyst Prior Vitrification</brief_title>
  <acronym>AS</acronym>
  <official_title>Removal of Blastocoel Fluid Before Blastocyst Vitrification by Laser Pulse and Its Effect on Clinical Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dar AlMaraa Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dar AlMaraa Center</source>
  <brief_summary>
    <textblock>
      Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating&#xD;
      a large hole in the zona pellucida at the cellular junction of the trophectoderm cells&#xD;
      located far away from the inner cell mass with a laser pulse before vitrification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human blastocyst formation begins about 5 days after injecting a single sperm into an oocyte&#xD;
      in ICSI cycle or incubation of them in IVF cycle. Human blastocyst consists of cells forming&#xD;
      an outer layer called trophotoderm that will form the placenta in case of successful&#xD;
      implantation, an inner cell mass which become the fetus, a fluid-filled blastocoel cavity in&#xD;
      the center, and a surrounding zone pellucida from which the embryo hatches to implant in the&#xD;
      uterus. Human blastocyst contains a large amount of liquid in the blastocoel, which alters&#xD;
      the infiltration of vitrification solution during the vitrification procedures leading to ice&#xD;
      crystal formation. Therefore, investigators need to compare blastocyst survival, clinical&#xD;
      pregnancy and implantation rates between vitrified untreated expanded blastocysts and&#xD;
      vitrified blastocysts with artificially eliminated blastocoels by a laser pulse prior to&#xD;
      vitrification&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>1 month</time_frame>
    <description>number of intrauterine gestational sacs over the total number of embryos transferred</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Vitrification</condition>
  <arm_group>
    <arm_group_label>Artificial shrinkage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without Artificial shrinkage</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Vitrify expanded blastocysts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Artificial shrinkage</intervention_name>
    <description>Artificially eliminated blastocoelic fluid before vitrification procedures.</description>
    <arm_group_label>Artificial shrinkage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI of ≤ 32&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-expanded blastocysts.&#xD;
&#xD;
          -  Women who had uterine pathology or abnormality.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yasmin Magdi, M.Sc</last_name>
    <phone>+201282313979</phone>
    <email>yas.magdi@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yasmin Magdi</name>
      <address>
        <city>Benha</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yasmin Magdi, M.Sc</last_name>
      <phone>+201282313979</phone>
      <email>yas.magdi@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dar AlMaraa Center</investigator_affiliation>
    <investigator_full_name>Yasmin</investigator_full_name>
    <investigator_title>Scientific IVF lab director</investigator_title>
  </responsible_party>
  <!-- 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/NCT02976662
org study id: 006735
nct id: NCT02976662
lead sponsor: 
collaborator: 
Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating
      a large hole in the zona pellucida at the cellular junction of the trophectoderm cells
      located far away from the inner cell mass with a laser pulse before vitrification.
Human blastocyst formation begins about 5 days after injecting a single sperm into an oocyte
      in ICSI cycle or incubation of them in IVF cycle. Human blastocyst consists of cells forming
      an outer layer called trophotoderm that will form the placenta in case of successful
      implantation, an inner cell mass which become the fetus, a fluid-filled blastocoel cavity in
      the center, and a surrounding zone pellucida from which the embryo hatches to implant in the
      uterus. Human blastocyst contains a large amount of liquid in the blastocoel, which alters
      the infiltration of vitrification solution during the vitrification procedures leading to ice
      crystal formation. Therefore, investigators need to compare blastocyst survival, clinical
      pregnancy and implantation rates between vitrified untreated expanded blastocysts and
      vitrified blastocysts with artificially eliminated blastocoels by a laser pulse prior to
      vitrification
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Implantation rate
time frame: 1 month
description: number of intrauterine gestational sacs over the total number of embryos transferred
arm group label: Artificial shrinkage
arm group type: Experimental
description: Elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.
arm group label: Without Artificial shrinkage
arm group type: No Intervention
description: Vitrify expanded blastocysts.
intervention type: Procedure
intervention name: Artificial shrinkage
description: Artificially eliminated blastocoelic fluid before vitrification procedures.
arm group label: Artificial shrinkage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Yasmin Magdi, M.Sc
phone: +201282313979
email: yas.magdi@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Dar AlMaraa Center
investigator full name: Yasmin
investigator title: Scientific IVF lab director