<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/NCT03240302</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0069-17</org_study_id>
    <nct_id>NCT03240302</nct_id>
  </id_info>
  <brief_title>A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI 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. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)</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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 using a standard ICSI petri dish.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PICSI Procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The PICSI procedure is based on a selection of mature spermatozoa with CD44 receptors and their injection into the oocyte using the PICSI petri dish that has been coated with hyaluronic acid on its bottom.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ICSI petri dish</intervention_name>
    <description>Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.</description>
    <arm_group_label>ICSI Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICSI petri dish</intervention_name>
    <description>Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.</description>
    <arm_group_label>PICSI 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 with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF&#xD;
             cycle&#xD;
&#xD;
          -  Males with normozoospermia with at least 2 unexplained failed IVF cycles&#xD;
&#xD;
          -  Females with normal FSH and normal AMH values&#xD;
&#xD;
          -  Females who have retrieved in previous cycles at least 6 oocytes&#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>Hadera</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/NCT03240302
org study id: HYMC-0069-17
nct id: NCT03240302
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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 PICSI 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 using a standard ICSI petri dish.
arm group label: PICSI Procedure
arm group type: Active Comparator
description: The PICSI procedure is based on a selection of mature spermatozoa with CD44 receptors and their injection into the oocyte using the PICSI petri dish that has been coated with hyaluronic acid on its bottom.
intervention type: Device
intervention name: ICSI petri dish
description: Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.
arm group label: ICSI Procedure
intervention type: Device
intervention name: PICSI petri dish
description: Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.
arm group label: PICSI 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