<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/NCT03240276</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0070-17</org_study_id>
    <nct_id>NCT03240276</nct_id>
  </id_info>
  <brief_title>A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method</brief_title>
  <official_title>A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. an Ultra Morphology Section Method - Intracytoplasmic Morphology Selected Sperm Injection (IMSI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research is to compare sibling oocytes using two sperm selection methods for&#xD;
      choosing the best quality spermatozoa before they are injected into oocytes and the influence&#xD;
      of each of these methods on embryo quality and IVF outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of fertilization rate</measure>
    <time_frame>Three years</time_frame>
    <description>Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and IMSI methods will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of embryo quality</measure>
    <time_frame>Three years</time_frame>
    <description>Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and IMSI methods will be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>Three years</time_frame>
    <description>Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and IMSI methods will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>Three years</time_frame>
    <description>Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and IMSI methods will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage rate</measure>
    <time_frame>Three years</time_frame>
    <description>Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and IMSI methods will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>Three years</time_frame>
    <description>Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and IMSI methods will be compared.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>ICSI Procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMSI Procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard ICSI procedure for sperm injection into oocyte</intervention_name>
    <description>The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes</description>
    <arm_group_label>ICSI Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MSOME</intervention_name>
    <description>Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification</description>
    <arm_group_label>IMSI Procedure</arm_group_label>
    <other_name>Motile Sperm Organelle Morphology Examination</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IMSI Procedure</intervention_name>
    <description>Injection of sperm that has been selected by the MSOME method into oocytes</description>
    <arm_group_label>IMSI Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males aged 18-60&#xD;
&#xD;
          -  Females aged 18-35&#xD;
&#xD;
          -  Males defined as Moderate OTA or Isolated Teratozoospermia with less than 4%&#xD;
             morphologically normal spermatozoa&#xD;
&#xD;
          -  Patients with 0.5- 7% normal sperm according to MSOME analysis&#xD;
&#xD;
          -  Females with normal FSH and AMH values&#xD;
&#xD;
          -  Females who have retrieved at least 6 oocytes in previous cycles&#xD;
&#xD;
          -  Couples who have had at least 2 failed IVF-ICSI cycles&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Couples who have been exposed to heavy smoking, drugs and chronic diseases&#xD;
&#xD;
          -  Males who have undergone testicular surgery (TESE) or defined as severe OTA&#xD;
&#xD;
          -  Females with egg factor infertility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Einat Shalom Paz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Medeia Michaeli, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Medeia Michaeli, PhD</last_name>
    <phone>972-50-6246885</phone>
    <email>medeia.michaeli@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>H̱adera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Medeia Michaeli, PhD</last_name>
      <phone>972-50-6246885</phone>
      <email>medeia.michaeli@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <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/NCT03240276
org study id: HYMC-0070-17
nct id: NCT03240276
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this research is to compare sibling oocytes using two sperm selection methods for
      choosing the best quality spermatozoa before they are injected into oocytes and the influence
      of each of these methods on embryo quality and IVF outcome.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of fertilization rate
time frame: Three years
description: Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and IMSI methods will be compared.
measure: Comparison of embryo quality
time frame: Three years
description: Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and IMSI methods will be compared.
measure: Implantation rate
time frame: Three years
description: Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and IMSI methods will be compared.
measure: Pregnancy rate
time frame: Three years
description: Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and IMSI methods will be compared.
measure: Miscarriage rate
time frame: Three years
description: Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and IMSI methods will be compared.
measure: Live birth rate
time frame: Three years
description: Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and IMSI methods will be compared.
arm group label: ICSI Procedure
arm group type: Active Comparator
description: The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte
arm group label: IMSI Procedure
arm group type: Active Comparator
description: The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)
intervention type: Other
intervention name: Standard ICSI procedure for sperm injection into oocyte
description: The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes
arm group label: ICSI Procedure
intervention type: Device
intervention name: MSOME
description: Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification
arm group label: IMSI Procedure
other name: Motile Sperm Organelle Morphology Examination
intervention type: Other
intervention name: IMSI Procedure
description: Injection of sperm that has been selected by the MSOME method into oocytes
arm group label: IMSI Procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Einat Shalom Paz, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Medeia Michaeli, PhD
role: Study Director
affiliation: Hillel Yaffe Medical Center
last name: Medeia Michaeli, PhD
phone: 972-50-6246885
email: medeia.michaeli@gmail.com
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: No