<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/NCT02992665</url>
  </required_header>
  <id_info>
    <org_study_id>CaII</org_study_id>
    <nct_id>NCT02992665</nct_id>
  </id_info>
  <brief_title>Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?</brief_title>
  <official_title>Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the impact of the use of calcium ionophore on the&#xD;
      ICSI outcomes in couples with severe male factor infertility. Investigators conduct a&#xD;
      randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in&#xD;
      these cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Elevation of calcium levels inside the oocyte is one of the most initial steps which takes&#xD;
      place during normal fertilization (1). The interaction between the sperm and oocytes surface&#xD;
      protein receptors may be the triggering event for oocyte activation during the process of&#xD;
      fertilization (2). It is suggested that the process of intracellular Calcium elevation is&#xD;
      triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts&#xD;
      (3). Severe male factor couples might have compromised fertilization and pregnancy outcomes&#xD;
      (4).&#xD;
&#xD;
      A prospective multicenter non-randomized study indicated that calcium ionophore could improve&#xD;
      the fertilization as well as the clinical pregnancy rates in these patients (5). On the other&#xD;
      hand, a randomized controlled trial did not find any significance for the use of calcium&#xD;
      ionophore in the couples with poor ovarian reserve with regards the fertilization and&#xD;
      clinical pregnancy rates (6). The purpose of this study is to determine the impact of the use&#xD;
      of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility.&#xD;
      Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use&#xD;
      of calcium ionophore in these cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>18 hours after injecting the sperms in the oocytes</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>In Vitro Fertilization</condition>
  <condition>Male Factor Infertility</condition>
  <arm_group>
    <arm_group_label>Ca ionophore</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo was used to control the group of Calcium ionophore</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ca Ionophore A23187</intervention_name>
    <description>Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters</description>
    <arm_group_label>Ca ionophore</arm_group_label>
    <other_name>Ca ionophore</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is used to control Ca ionophore group</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe male factor infertility, Average response to COH,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor responders,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osama Abdalmageed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women health center, Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Osama Abdalmageed</last_name>
    <email>drosamast1981@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Osama Abdalmageed</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Osama Abdalmageed</last_name>
      <phone>1007972027</phone>
      <email>drosamast@yahoo.com.au</email>
    </contact>
    <contact_backup>
      <last_name>Osama Abdalmageed</last_name>
      <phone>1007972027</phone>
      <phone_ext>Abdalmageed</phone_ext>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Osama Saber Thabet Abdalmageed</investigator_full_name>
    <investigator_title>Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity</investigator_title>
  </responsible_party>
  <keyword>Calcium ionophore</keyword>
  <keyword>Fertilization</keyword>
  <keyword>Sperm</keyword>
  <keyword>Oocyte</keyword>
  <keyword>ICSI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ionophores</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>According to the patient agreement.</ipd_description>
  </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/NCT02992665
org study id: CaII
nct id: NCT02992665
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the impact of the use of calcium ionophore on the
      ICSI outcomes in couples with severe male factor infertility. Investigators conduct a
      randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in
      these cases.
Elevation of calcium levels inside the oocyte is one of the most initial steps which takes
      place during normal fertilization (1). The interaction between the sperm and oocytes surface
      protein receptors may be the triggering event for oocyte activation during the process of
      fertilization (2). It is suggested that the process of intracellular Calcium elevation is
      triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts
      (3). Severe male factor couples might have compromised fertilization and pregnancy outcomes
      (4).

      A prospective multicenter non-randomized study indicated that calcium ionophore could improve
      the fertilization as well as the clinical pregnancy rates in these patients (5). On the other
      hand, a randomized controlled trial did not find any significance for the use of calcium
      ionophore in the couples with poor ovarian reserve with regards the fertilization and
      clinical pregnancy rates (6). The purpose of this study is to determine the impact of the use
      of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility.
      Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use
      of calcium ionophore in these cases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Fertilization rate
time frame: 18 hours after injecting the sperms in the oocytes
arm group label: Ca ionophore
arm group type: Experimental
description: Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility.
arm group label: Placebo
arm group type: Experimental
description: Placebo was used to control the group of Calcium ionophore
intervention type: Drug
intervention name: Ca Ionophore A23187
description: Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters
arm group label: Ca ionophore
other name: Ca ionophore
intervention type: Other
intervention name: Placebo
description: Placebo is used to control Ca ionophore group
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Osama Abdalmageed
role: Principal Investigator
affiliation: Women health center, Assiut University
last name: Osama Abdalmageed
email: drosamast1981@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Osama Saber Thabet Abdalmageed
investigator title: Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity
mesh term: Infertility
mesh term: Ionophores
sharing ipd: Undecided
ipd description: According to the patient agreement.