<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/NCT04496232</url>
  </required_header>
  <id_info>
    <org_study_id>GFC-004</org_study_id>
    <nct_id>NCT04496232</nct_id>
  </id_info>
  <brief_title>Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial</brief_title>
  <official_title>Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial</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>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>
      Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of&#xD;
      abnormal sperm DNA fragmentation in patients undergoing ICSI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization,&#xD;
      implantation, clinical pregnancy, and live birth rates. And a positive correlation with the&#xD;
      miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second&#xD;
      ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a&#xD;
      robust sperm selection technique that can select individual mature intact sperm DNA. In our&#xD;
      study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a&#xD;
      natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a&#xD;
      control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>16-19 hours</time_frame>
    <description>Defined as the proportion of fertilized oocytes over the injected oocytes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cleavage rate</measure>
    <time_frame>3 days</time_frame>
    <description>Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blastulation rate</measure>
    <time_frame>5-6 days</time_frame>
    <description>Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blastocyst quality rate</measure>
    <time_frame>5-6 days</time_frame>
    <description>Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair, or bad in terms of percentage of the total formed blastocysts.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Male Infertility</condition>
  <arm_group>
    <arm_group_label>Normal SDF</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Using routine semen processing method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiological ICSI (PICSI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second ejaculate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICSI</intervention_name>
    <description>Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate</description>
    <arm_group_label>Physiological ICSI (PICSI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Second ejaculate</intervention_name>
    <description>Semen processing by density gradient centrifugation for the second ejaculate</description>
    <arm_group_label>Second ejaculate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male partner with abnormal sperm DNA fragmentation index (&gt;20%) by TUNEL assay&#xD;
&#xD;
          -  Male partner with at least 1 million progressive motile count&#xD;
&#xD;
          -  Male aged 18-50 years&#xD;
&#xD;
          -  Male with adjusted sexual abstinence days (1-2 days)&#xD;
&#xD;
          -  Female aged 18-37 years&#xD;
&#xD;
          -  Normo-responder females (at least 5 mature oocytes)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Leukocytospermia&#xD;
&#xD;
          -  Varicocele&#xD;
&#xD;
          -  Known genetic abnormality&#xD;
&#xD;
          -  Use of oocyte or sperm donors&#xD;
&#xD;
          -  Use of a gestational carrier&#xD;
&#xD;
          -  Presence of any endometrial factors that can affect embryo implantation&#xD;
&#xD;
          -  Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eman Hasanen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Radwa Omar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanaa Alkhader</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam Zaki, MSc, FRCOG</last_name>
    <role>Study Director</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manar Hozayen, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ganin Fertility Center</name>
      <address>
        <city>Cairo</city>
        <state>القاهرة</state>
        <zip>11728</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 6, 2022</last_update_submitted>
  <last_update_submitted_qc>August 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ganin Fertility Center</investigator_affiliation>
    <investigator_full_name>Eman Hasanen</investigator_full_name>
    <investigator_title>BSc.</investigator_title>
  </responsible_party>
  <keyword>Sperm DNA fragmentation</keyword>
  <keyword>Second ejaculate</keyword>
  <keyword>Sperm Selection</keyword>
  <keyword>PICSI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT04496232
org study id: GFC-004
nct id: NCT04496232
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of
      abnormal sperm DNA fragmentation in patients undergoing ICSI.
Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization,
      implantation, clinical pregnancy, and live birth rates. And a positive correlation with the
      miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second
      ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a
      robust sperm selection technique that can select individual mature intact sperm DNA. In our
      study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a
      natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a
      control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Fertilization rate
time frame: 16-19 hours
description: Defined as the proportion of fertilized oocytes over the injected oocytes.
measure: Cleavage rate
time frame: 3 days
description: Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
measure: Blastulation rate
time frame: 5-6 days
description: Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
measure: Blastocyst quality rate
time frame: 5-6 days
description: Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair, or bad in terms of percentage of the total formed blastocysts.
arm group label: Normal SDF
arm group type: No Intervention
description: Using routine semen processing method
arm group label: Physiological ICSI (PICSI)
arm group type: Active Comparator
description: Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI
arm group label: Second ejaculate
arm group type: Active Comparator
description: Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI
intervention type: Device
intervention name: PICSI
description: Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
arm group label: Physiological ICSI (PICSI)
intervention type: Other
intervention name: Second ejaculate
description: Semen processing by density gradient centrifugation for the second ejaculate
arm group label: Second ejaculate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Eman Hasanen
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Radwa Omar
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hanaa Alkhader
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hosam Zaki, MSc, FRCOG
role: Study Director
affiliation: Ganin Fertility Center
last name: Manar Hozayen, MSc.
role: Principal Investigator
affiliation: Ganin Fertility Center
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ganin Fertility Center
investigator full name: Eman Hasanen
investigator title: BSc.
mesh term: Infertility
mesh term: Infertility, Male
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)