<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/NCT03778736</url>
  </required_header>
  <id_info>
    <org_study_id>IbnSina-Cumulase</org_study_id>
    <nct_id>NCT03778736</nct_id>
  </id_info>
  <brief_title>Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes</brief_title>
  <official_title>Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ibn Sina Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Banoon IVF Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quena IVF Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ibn Sina Hospital</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 cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to&#xD;
      intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived&#xD;
      hyaluronidase followed by mechanical denudation through pipetting. A human recombinant&#xD;
      hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns&#xD;
      associated with the animal origin and lack of purity of the bovine-derived form of the&#xD;
      enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs&#xD;
      or lower remains an open question.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2018</start_date>
  <completion_date type="Actual">August 5, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>16 weeks</time_frame>
    <description>Continued pregnancy after 12 weeks of gestation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical pregnancy</measure>
    <time_frame>Two weeks</time_frame>
    <description>Positive b-hCG at two weeks or more after embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>7 weeks</time_frame>
    <description>Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Embryo developmental rate</measure>
    <time_frame>6 days of culture</time_frame>
    <description>fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">586</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Cumulase denudation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyaluronidase denudation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cumulase denudation</intervention_name>
    <description>Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve</description>
    <arm_group_label>Cumulase denudation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICSI indicated partcipants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe medical disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Banon Assiut</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qena Fertility Center</name>
      <address>
        <city>Qena</city>
        <zip>123456</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IbnSina IVF Center</name>
      <address>
        <city>Sohag</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ibn Sina Hospital</investigator_affiliation>
    <investigator_full_name>Muhammad Fawzy</investigator_full_name>
    <investigator_title>IVF Lab Director</investigator_title>
  </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/NCT03778736
org study id: IbnSina-Cumulase
nct id: NCT03778736
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to
      intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived
      hyaluronidase followed by mechanical denudation through pipetting. A human recombinant
      hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns
      associated with the animal origin and lack of purity of the bovine-derived form of the
      enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs
      or lower remains an open question.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Ongoing pregnancy rate
time frame: 16 weeks
description: Continued pregnancy after 12 weeks of gestation
measure: Biochemical pregnancy
time frame: Two weeks
description: Positive b-hCG at two weeks or more after embryo transfer
measure: Clinical pregnancy rate
time frame: 7 weeks
description: Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation
measure: Embryo developmental rate
time frame: 6 days of culture
description: fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes
arm group label: Cumulase denudation
arm group type: Experimental
arm group label: Hyaluronidase denudation
arm group type: No Intervention
intervention type: Other
intervention name: Cumulase denudation
description: Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve
arm group label: Cumulase denudation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ibn Sina Hospital
investigator full name: Muhammad Fawzy
investigator title: IVF Lab Director
mesh term: Infertility
sharing ipd: No