<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/NCT02265055</url>
  </required_header>
  <id_info>
    <org_study_id>u12345</org_study_id>
    <nct_id>NCT02265055</nct_id>
  </id_info>
  <brief_title>Early Embryo Cleavage And Multiple Pregnancies After ICSI</brief_title>
  <official_title>Early Embryo Cleavage And Multiple Pregnancies After ICSI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <brief_summary>
    <textblock>
      To observe whether Number of early cleavage embryos can be a predictor for multiple&#xD;
      pregnancies after ICSI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 193 infertile couples, attending the ART unit, International Islamic Center for&#xD;
      Population Studies and Research (IICPSR), -Al- Azhar University in the period from December&#xD;
      2010 to September 2012, were included in this study.&#xD;
&#xD;
      The controlled ovarian hyperstimulation protocol was performed according to a long GnRH&#xD;
      agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos&#xD;
      were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell&#xD;
      stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as&#xD;
      Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for&#xD;
      day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos,&#xD;
      according to day 3 embryo morphology were transferred. The patients were subdivided into two&#xD;
      subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non&#xD;
      early cleavage embryo (NEC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical pregnancy</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>multiple pregnancy</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">193</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>transfer early cleavage embryos (EC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>transfer early cleavage embryos</description>
  </arm_group>
  <arm_group>
    <arm_group_label>transfer non early cleavage embryo (NEC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>transfer non early cleavage embryos</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transfer early cleavage embryos</intervention_name>
    <description>transfer early cleavage embryos</description>
    <arm_group_label>transfer early cleavage embryos (EC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transfer non early cleavage embryo</intervention_name>
    <arm_group_label>transfer non early cleavage embryo (NEC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;25 - 30 kg/m2&#xD;
&#xD;
          -  Have two ovaries&#xD;
&#xD;
          -  Regular cycles&#xD;
&#xD;
          -  first ICSI cycle&#xD;
&#xD;
          -  Long midluteal GnRH protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uterine factor as a cause of female factor infertility&#xD;
&#xD;
          -  pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)&#xD;
&#xD;
          -  history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver&#xD;
             diseases, renal diseases,...)&#xD;
&#xD;
          -  azoospermia as a cause of male factor infertility&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mahmoud edessy, prof</last_name>
    <role>Study Director</role>
    <affiliation>ALAZHAR UNIVERSITY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>abd elnasr m ali, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>ALAZHAR UNIVERSITY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ahmed fata, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>ALAZHAR UNIVERSITY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>wael hamed, dr</last_name>
    <role>Study Chair</role>
    <affiliation>ALAZHAR UNIVERSITY</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Edessy Mahmoud</investigator_full_name>
    <investigator_title>Obstetrics and Gynecology Department, faculty of medicine (Assiut)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT02265055
org study id: u12345
nct id: NCT02265055
lead sponsor: 
To observe whether Number of early cleavage embryos can be a predictor for multiple
      pregnancies after ICSI.
A total of 193 infertile couples, attending the ART unit, International Islamic Center for
      Population Studies and Research (IICPSR), -Al- Azhar University in the period from December
      2010 to September 2012, were included in this study.

      The controlled ovarian hyperstimulation protocol was performed according to a long GnRH
      agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos
      were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell
      stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as
      Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for
      day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos,
      according to day 3 embryo morphology were transferred. The patients were subdivided into two
      subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non
      early cleavage embryo (NEC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: clinical pregnancy
time frame: 6 weeks
measure: multiple pregnancy
time frame: 8 weeks
arm group label: transfer early cleavage embryos (EC)
arm group type: Active Comparator
description: transfer early cleavage embryos
arm group label: transfer non early cleavage embryo (NEC)
arm group type: Active Comparator
description: transfer non early cleavage embryos
intervention type: Procedure
intervention name: transfer early cleavage embryos
description: transfer early cleavage embryos
arm group label: transfer early cleavage embryos (EC)
intervention type: Procedure
intervention name: transfer non early cleavage embryo
arm group label: transfer non early cleavage embryo (NEC)
criteria: 
gender: Female
minimum age: N/A
maximum age: 35 Years
healthy volunteers: No
last name: mahmoud edessy, prof
role: Study Director
affiliation: ALAZHAR UNIVERSITY
last name: abd elnasr m ali, prof
role: Principal Investigator
affiliation: ALAZHAR UNIVERSITY
last name: ahmed fata, prof
role: Principal Investigator
affiliation: ALAZHAR UNIVERSITY
last name: wael hamed, dr
role: Study Chair
affiliation: ALAZHAR UNIVERSITY
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Edessy Mahmoud
investigator title: Obstetrics and Gynecology Department, faculty of medicine (Assiut)
mesh term: Infertility