<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/NCT01727947</url>
  </required_header>
  <id_info>
    <org_study_id>MSOME_SLV</org_study_id>
    <nct_id>NCT01727947</nct_id>
  </id_info>
  <brief_title>Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes</brief_title>
  <official_title>Influence of Sperm With Large Nuclear Vacuoles on the Cycles' Outcomes of Couples Couples Undergoing ICSI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sapientiae Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sapientiae Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current research on sperm morphology has been directed towards the dysmorphisms of the sperm&#xD;
      head. A new technique based on the motile sperm organelle morphology examination (MSOME)&#xD;
      allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are&#xD;
      specific sperm alterations observed under high magnification, and their presence has been&#xD;
      related to increased DNA fragmentation and denaturation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A new method for the detailed morphological evaluation of motile spermatozoa in real time,&#xD;
      under high magnification, named &quot;motile sperm organellar morphology examination&quot; (MSOME) was&#xD;
      developed. This magnification provides an accurate description of spermatozoa abnormalities,&#xD;
      particularly the presence of head vacuoles, which is indicative of abnormal chromatin&#xD;
      packaging in spermatozoa. However, the influence of sperm with large nuclear vacuoles (SLV)&#xD;
      on ART outcomes is still a matter of debate. The goals for this study were to identify&#xD;
      whether there is a connection between SLV under high magnification and ICSI outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy</measure>
    <time_frame>1 month</time_frame>
    <description>Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>MSOME</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Couples in which the sperm cells were analysed through MSOME</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MSOME</intervention_name>
    <description>A total of 200 spermatozoa of each sample will be analyzed under high magnification (x6600) and the incidence of SLV (sperm cells presenting at least one vacuole that occupied &gt; 13% of nuclear area) in each sample will be assessed.</description>
    <arm_group_label>MSOME</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Couples undergoing intracytoplasmic sperm injection (ICSI) as result of male factor or&#xD;
             tubal factor or unexplained infertility&#xD;
&#xD;
          -  Women with regular menstrual cycles of 25-35 days&#xD;
&#xD;
          -  Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone&#xD;
             (LH) levels&#xD;
&#xD;
          -  Women with body mass index (BMI) less than 30 kg/m2&#xD;
&#xD;
          -  Women with both ovaries and intact uterus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with polycystic ovaries syndrome&#xD;
&#xD;
          -  Women with endometriosis&#xD;
&#xD;
          -  Women with gynaecological/medical disorders&#xD;
&#xD;
          -  Couples with any sexually transmitted disease&#xD;
&#xD;
          -  Women who had received any hormone therapy for less than 60 days preceding the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edson Borges Jr., MD., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sapientiae Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sapientiae Institute</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04503-040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01727947
org study id: MSOME_SLV
nct id: NCT01727947
lead sponsor: 
has dmc: No
Current research on sperm morphology has been directed towards the dysmorphisms of the sperm
      head. A new technique based on the motile sperm organelle morphology examination (MSOME)
      allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are
      specific sperm alterations observed under high magnification, and their presence has been
      related to increased DNA fragmentation and denaturation.
A new method for the detailed morphological evaluation of motile spermatozoa in real time,
      under high magnification, named "motile sperm organellar morphology examination" (MSOME) was
      developed. This magnification provides an accurate description of spermatozoa abnormalities,
      particularly the presence of head vacuoles, which is indicative of abnormal chromatin
      packaging in spermatozoa. However, the influence of sperm with large nuclear vacuoles (SLV)
      on ART outcomes is still a matter of debate. The goals for this study were to identify
      whether there is a connection between SLV under high magnification and ICSI outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Pregnancy
time frame: 1 month
description: Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed
arm group label: MSOME
arm group type: Experimental
description: Couples in which the sperm cells were analysed through MSOME
intervention type: Other
intervention name: MSOME
description: A total of 200 spermatozoa of each sample will be analyzed under high magnification (x6600) and the incidence of SLV (sperm cells presenting at least one vacuole that occupied > 13% of nuclear area) in each sample will be assessed.
arm group label: MSOME
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edson Borges Jr., MD., PhD
role: Principal Investigator
affiliation: Sapientiae Institute
facility: 
country: Brazil
responsible party type: Sponsor