<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/NCT04482517</url>
  </required_header>
  <id_info>
    <org_study_id>MH-005</org_study_id>
    <nct_id>NCT04482517</nct_id>
  </id_info>
  <brief_title>Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.</brief_title>
  <official_title>Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation</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>No</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 the reproductive outcomes of different sperm selection techniques; Density gradient&#xD;
      centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic&#xD;
      activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>14 days following embryo transfer</time_frame>
    <description>Defined as clinical pregnancy per transfer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>6- 8 weeks following embryo transfer</time_frame>
    <description>Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>20 weeks of gestation</time_frame>
    <description>Defined as the proportion of pregnancies that completed more than 20 weeks of gestation</description>
  </primary_outcome>
  <secondary_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>
  </secondary_outcome>
  <secondary_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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High quality blastocyst 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage rate</measure>
    <time_frame>20 weeks of gestation</time_frame>
    <description>Defined as the proportion of miscarried cases</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Infertility, Male</condition>
  <arm_group>
    <arm_group_label>Density Gradient Centrifugation (DGC)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Using the routine DGC sperm processing only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiological ICSI (PICSI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using PICSI dish for selecting sperm with lower sperm DNA fragmentation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnetic Activated Cell Sorting (MACS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using MACS for selecting sperm with lower sperm DNA fragmentation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testicular sperm (Testi)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using testicular sperm not ejaculated sperm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Density Gradient Centrifugation</intervention_name>
    <description>Semen processing is done by double layer density gradient method.</description>
    <arm_group_label>Density Gradient Centrifugation (DGC)</arm_group_label>
    <other_name>DGC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiological ICSI</intervention_name>
    <description>Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head</description>
    <arm_group_label>Physiological ICSI (PICSI)</arm_group_label>
    <other_name>PICSI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic activated cell sorting</intervention_name>
    <description>Sperm selection by using Annexin V micro-beads and separation columns</description>
    <arm_group_label>Magnetic Activated Cell Sorting (MACS)</arm_group_label>
    <other_name>MACS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Testicular sperm</intervention_name>
    <description>Using testicular sperm retrieved by TESA or TESE</description>
    <arm_group_label>Testicular sperm (Testi)</arm_group_label>
    <other_name>Testi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female age was ≤37 years&#xD;
&#xD;
          -  Female should has 5≥ metaphase II oocytes&#xD;
&#xD;
          -  Males having abnormal SDF levels ≥ 20.3% by TUNEL assay&#xD;
&#xD;
          -  Abstinence from 1 to 2 days&#xD;
&#xD;
          -  Males having at least 1 million total motile progressive count&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Leukocytospermia&#xD;
&#xD;
          -  Presence of varicocele.&#xD;
&#xD;
          -  Known genetic abnormality&#xD;
&#xD;
          -  Use of sperm donation or cryopreserved sperm&#xD;
&#xD;
          -  Use of Oocyte donation&#xD;
&#xD;
          -  Use of gestational carrier&#xD;
&#xD;
          -  Presence of any of the endometrial factors that affect embryo implantation such as&#xD;
             hydrosalpings, adenomyosis or previous uterine infection&#xD;
&#xD;
          -  Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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>khaled Elqusi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salma Eltanbouly</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samar Gamal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abd ElGhafar Hussin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanaa Elkhadr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam Zaki</last_name>
    <role>Study Chair</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ganin Fertility Center</name>
      <address>
        <city>Cairo</city>
        <state>Maadi</state>
        <zip>1728</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sperm DNA fragmentation</keyword>
  <keyword>PICSI</keyword>
  <keyword>MACS</keyword>
  <keyword>Sperm Selection</keyword>
  <keyword>DGC</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>
  <!-- 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/NCT04482517
org study id: MH-005
nct id: NCT04482517
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparing the reproductive outcomes of different sperm selection techniques; Density gradient
      centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic
      activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical pregnancy rate
time frame: 14 days following embryo transfer
description: Defined as clinical pregnancy per transfer
measure: Implantation rate
time frame: 6- 8 weeks following embryo transfer
description: Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
measure: Ongoing pregnancy rate
time frame: 20 weeks of gestation
description: Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
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: High quality blastocyst 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
measure: Miscarriage rate
time frame: 20 weeks of gestation
description: Defined as the proportion of miscarried cases
arm group label: Density Gradient Centrifugation (DGC)
arm group type: Other
description: Using the routine DGC sperm processing only
arm group label: Physiological ICSI (PICSI)
arm group type: Active Comparator
description: Using PICSI dish for selecting sperm with lower sperm DNA fragmentation
arm group label: Magnetic Activated Cell Sorting (MACS)
arm group type: Active Comparator
description: Using MACS for selecting sperm with lower sperm DNA fragmentation
arm group label: Testicular sperm (Testi)
arm group type: Active Comparator
description: Using testicular sperm not ejaculated sperm
intervention type: Other
intervention name: Density Gradient Centrifugation
description: Semen processing is done by double layer density gradient method.
arm group label: Density Gradient Centrifugation (DGC)
other name: DGC
intervention type: Other
intervention name: Physiological ICSI
description: Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head
arm group label: Physiological ICSI (PICSI)
other name: PICSI
intervention type: Other
intervention name: Magnetic activated cell sorting
description: Sperm selection by using Annexin V micro-beads and separation columns
arm group label: Magnetic Activated Cell Sorting (MACS)
other name: MACS
intervention type: Other
intervention name: Testicular sperm
description: Using testicular sperm retrieved by TESA or TESE
arm group label: Testicular sperm (Testi)
other name: Testi
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Eman Hasanen
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: khaled Elqusi
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Salma Eltanbouly
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Samar Gamal
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Abd ElGhafar Hussin
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hanaa Elkhadr
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hosam Zaki
role: Study Chair
affiliation: Ganin Fertility Center
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Male