<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/NCT04455412</url>
  </required_header>
  <id_info>
    <org_study_id>RoyalFertility 001</org_study_id>
    <nct_id>NCT04455412</nct_id>
  </id_info>
  <brief_title>Laser Assisted ICSI; Has it Role Whatsoever?</brief_title>
  <official_title>Laser Assisted ICSI; Has it Role Whatsoever? Does it Affect the ICSI Outcome Positively?1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Fertility Center, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Fertility Center, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI&#xD;
      technique with assisted hatching.This procedure is usually used for MII oocytes possessing&#xD;
      oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Especially&#xD;
      because data indicated that in addition to an improved oocyte survival, this new approach&#xD;
      increases the hatching rate in vitro. But since it is still debatable that such a small&#xD;
      opening might impair the hatching process, so modified zona thinning technique was proposed&#xD;
      for more embryo safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to compare the LA- ICSI by drilling a micro hole (LAD-ICSI) and modified&#xD;
      LA-ICSI by zona pellucida thinning (LAT-ICSI) with conventional ICSI in order to effectively&#xD;
      assess whether this approach can be applied routinely to improve ICSI outcome.&#xD;
&#xD;
      One arm study divided into three interventions; Conventional ICSI (control group) was&#xD;
      compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes.&#xD;
&#xD;
      The rates of maturation, fertilization, Devision, Blastulation and good quality blastulation&#xD;
      rates were assessed in the three groups&#xD;
&#xD;
      Cases were randomly selected for embryo transfer from the three groups,Then chemical&#xD;
      pregnancy and clinical pregnancy rates were compared between the three groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    recruitment is stopped waiting for funds&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes. then Cases randomly selected for embryo transfer from each group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>three-four weeks after embryo transfer</time_frame>
    <description>confirmed by sac observation using ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blastulation rate</measure>
    <time_frame>5 days later after ICSI procedure</time_frame>
    <description>number of blastocysts that are grown from devided embryos</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hatching rate</measure>
    <time_frame>5 days later after ICSI procedure</time_frame>
    <description>number of blastocysts that hatch out of zona</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Laser Assistance to Improve ICSI Outcome</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional ICSI procedure was done for first portion of sibling oocytes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser assisted drilling ICSI procedure was done for second portion of sibling oocytes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser assisted thinning ICSI procedure was done for Third portion of sibling oocytes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser Assisted ICSI</intervention_name>
    <description>using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome</description>
    <arm_group_label>Study group 1</arm_group_label>
    <arm_group_label>Study group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 20 years old to 37 years old&#xD;
&#xD;
          -  good res-ponders&#xD;
&#xD;
          -  gives more than 15 oocytes&#xD;
&#xD;
          -  endometrial thickness more than 9 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  poor res-ponders&#xD;
&#xD;
          -  severe oligoasthinozoospermia of male partners&#xD;
&#xD;
          -  testicular samples&#xD;
&#xD;
          -  Poor quality oocytes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Fertility Center</name>
      <address>
        <city>Mansoura</city>
        <state>Daqahlia</state>
        <zip>12111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>September 18, 2022</last_update_submitted>
  <last_update_submitted_qc>September 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Laser assisted-ICSI</keyword>
  <keyword>Zona pellucida thinning</keyword>
  <keyword>ICSI</keyword>
  <keyword>embryo good quality rate</keyword>
  <keyword>hatching rate</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04455412
org study id: RoyalFertility 001
nct id: NCT04455412
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI
      technique with assisted hatching.This procedure is usually used for MII oocytes possessing
      oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Especially
      because data indicated that in addition to an improved oocyte survival, this new approach
      increases the hatching rate in vitro. But since it is still debatable that such a small
      opening might impair the hatching process, so modified zona thinning technique was proposed
      for more embryo safety.
This study aims to compare the LA- ICSI by drilling a micro hole (LAD-ICSI) and modified
      LA-ICSI by zona pellucida thinning (LAT-ICSI) with conventional ICSI in order to effectively
      assess whether this approach can be applied routinely to improve ICSI outcome.

      One arm study divided into three interventions; Conventional ICSI (control group) was
      compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes.

      The rates of maturation, fertilization, Devision, Blastulation and good quality blastulation
      rates were assessed in the three groups

      Cases were randomly selected for embryo transfer from the three groups,Then chemical
      pregnancy and clinical pregnancy rates were compared between the three groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes. then Cases randomly selected for embryo transfer from each group
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Clinical pregnancy rate
time frame: three-four weeks after embryo transfer
description: confirmed by sac observation using ultrasound
measure: Blastulation rate
time frame: 5 days later after ICSI procedure
description: number of blastocysts that are grown from devided embryos
measure: Hatching rate
time frame: 5 days later after ICSI procedure
description: number of blastocysts that hatch out of zona
arm group label: control group
arm group type: No Intervention
description: Conventional ICSI procedure was done for first portion of sibling oocytes
arm group label: Study group 1
arm group type: Experimental
description: Laser assisted drilling ICSI procedure was done for second portion of sibling oocytes
arm group label: Study group 2
arm group type: Experimental
description: Laser assisted thinning ICSI procedure was done for Third portion of sibling oocytes
intervention type: Procedure
intervention name: Laser Assisted ICSI
description: using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome
arm group label: Study group 1
arm group label: Study group 2
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 37 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Sponsor
sharing ipd: No