<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/NCT03778866</url>
  </required_header>
  <id_info>
    <org_study_id>IbnSina-HEPES</org_study_id>
    <nct_id>NCT03778866</nct_id>
  </id_info>
  <brief_title>Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate</brief_title>
  <official_title>Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muhammad Fawzy</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 pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is&#xD;
      physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed&#xD;
      whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better&#xD;
      outcomes. However, the oil use and time frame outside the incubators have not been accounted&#xD;
      for. This study is to evaluate the use of HEPES buffered medium compared with the&#xD;
      bicarbonate-buffered medium on ICSI outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">August 5, 2019</completion_date>
  <primary_completion_date type="Actual">August 5, 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>live birth rate</measure>
    <time_frame>40 weeks</time_frame>
    <description>viable neonate after 30 weeks of Gestation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>a positive heartbeat on ultrasound at ≥ 7 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biochemical pregnancy rate</measure>
    <time_frame>two weeks</time_frame>
    <description>positive b-hCG at ≥ 14 days following embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>embryo developmental rates</measure>
    <time_frame>6 days of culture</time_frame>
    <description>fertilized oocyte per injected ones and developed embryos per fertilized oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>16 weeks</time_frame>
    <description>Continued pregnancy after week 12 of gestation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1057</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Bicarbonate-buffered Medium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HEPES-MOPS-buffered Medium</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bicarbonate-buffered handling medium</intervention_name>
    <description>The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.</description>
    <arm_group_label>Bicarbonate-buffered Medium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICSI indicated cycles&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe medical illness&#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 17, 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>Sponsor-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/NCT03778866
org study id: IbnSina-HEPES
nct id: NCT03778866
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is
      physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed
      whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better
      outcomes. However, the oil use and time frame outside the incubators have not been accounted
      for. This study is to evaluate the use of HEPES buffered medium compared with the
      bicarbonate-buffered medium on ICSI outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: live birth rate
time frame: 40 weeks
description: viable neonate after 30 weeks of Gestation
measure: Clinical pregnancy rate
time frame: 12 weeks
description: a positive heartbeat on ultrasound at ≥ 7 weeks of gestation
measure: biochemical pregnancy rate
time frame: two weeks
description: positive b-hCG at ≥ 14 days following embryo transfer
measure: embryo developmental rates
time frame: 6 days of culture
description: fertilized oocyte per injected ones and developed embryos per fertilized oocytes
measure: Ongoing pregnancy rate
time frame: 16 weeks
description: Continued pregnancy after week 12 of gestation
arm group label: Bicarbonate-buffered Medium
arm group type: Experimental
arm group label: HEPES-MOPS-buffered Medium
arm group type: No Intervention
intervention type: Other
intervention name: Bicarbonate-buffered handling medium
description: The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.
arm group label: Bicarbonate-buffered Medium
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ibn Sina Hospital
investigator full name: Muhammad Fawzy
investigator title: IVF Lab Director
mesh term: Infertility
sharing ipd: No