<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/NCT03033563</url>
  </required_header>
  <id_info>
    <org_study_id>2017</org_study_id>
    <nct_id>NCT03033563</nct_id>
  </id_info>
  <brief_title>ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa</brief_title>
  <official_title>ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa in Cryptozoospermic or Severe Oligozoospermic Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adam International Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adam International Hospital</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>
      The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or&#xD;
      severe oligozoospermia after use of ejaculated versus extracted testicular sperms in&#xD;
      different cycles for the same patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor&#xD;
      infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in&#xD;
      this study.&#xD;
&#xD;
      First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if&#xD;
      no motile sperm was available. For failed cases a second cycle was repeated using either&#xD;
      testicular sperm or ejaculated sperm.&#xD;
&#xD;
      Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 1, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intracytoplasmic sperm injection outcome</measure>
    <time_frame>three years</time_frame>
    <description>Pregnancy rate.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">430</enrollment>
  <condition>Intracytoplasmic Sperm Injection</condition>
  <arm_group>
    <arm_group_label>Testicular tissue versus ejaculate</arm_group_label>
    <description>Evaluation of ICSI outcome.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intracytoplasmic sperm injection</intervention_name>
    <description>Intracytoplasmic sperm injection</description>
    <arm_group_label>Testicular tissue versus ejaculate</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile couples&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Couples seeking ICSI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Couples not seeking ICSI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adam International Hospital</investigator_affiliation>
    <investigator_full_name>Ahmad Raef Sadek</investigator_full_name>
    <investigator_title>Dr. Ahmad Raef</investigator_title>
  </responsible_party>
  <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/NCT03033563
org study id: 2017
nct id: NCT03033563
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or
      severe oligozoospermia after use of ejaculated versus extracted testicular sperms in
      different cycles for the same patient.
The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor
      infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in
      this study.

      First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if
      no motile sperm was available. For failed cases a second cycle was repeated using either
      testicular sperm or ejaculated sperm.

      Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.
observational model: Case-Only
time perspective: Retrospective
measure: Intracytoplasmic sperm injection outcome
time frame: three years
description: Pregnancy rate.
arm group label: Testicular tissue versus ejaculate
description: Evaluation of ICSI outcome.
intervention type: Procedure
intervention name: Intracytoplasmic sperm injection
description: Intracytoplasmic sperm injection
arm group label: Testicular tissue versus ejaculate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Adam International Hospital
investigator full name: Ahmad Raef Sadek
investigator title: Dr. Ahmad Raef
sharing ipd: No