<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/NCT01731639</url>
  </required_header>
  <id_info>
    <org_study_id>MSOME_Grades</org_study_id>
    <nct_id>NCT01731639</nct_id>
  </id_info>
  <brief_title>Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples</brief_title>
  <official_title>The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes</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>
      A new technique based on the motile sperm organelle morphology examination (MSOME) at a&#xD;
      magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both&#xD;
      shape and chromatin content, which is the most important sperm organelle in influencing&#xD;
      intracytoplasmic sperm injection (ICSI) outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sperm morphology has been described as one of the major determinants of male in vitro&#xD;
      fertility. However, the standard morphology evaluation on random stained cells from the&#xD;
      ejaculate is of limited value during ICSI. Current research is directed towards the&#xD;
      dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology&#xD;
      examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME&#xD;
      assesses the nucleus, for both shape and chromatin content, which is the most important sperm&#xD;
      organelle in influencing ICSI outcomes. The goals for this study are to identify whether&#xD;
      there is a connection between morphologic sperm normalcy under high magnification and (i)&#xD;
      semen analysis according to the new World Health Organization (WHO) reference values and (ii)&#xD;
      ICSI outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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 rates</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>
  <secondary_outcome>
    <measure>Implantation rates</measure>
    <time_frame>1 month</time_frame>
    <description>Number of gestational sacs divided by the number of transferred embryos.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>MSOME</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The samples will be evaluated under high magnification</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MSOME</intervention_name>
    <description>The semen samples will be evaluated according to the 2010 WHO reference values. After ICSI 200 spermatozoa of each sample will be analyzed under high magnification (MSOME - x6600) and graded into four groups according to the presence or size of the vacuoles. Grade I: normal form and no vacuoles; grade II: normal form and ≤ 2 small vacuoles; grade III: normal form &gt; 2 small vacuoles or at least one large vacuole and grade IV: large vacuole and abnormal head shapes or other abnormalities.</description>
    <arm_group_label>MSOME</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Couples undergoing ICSI as result of male factor or tubal factor or unexplained&#xD;
             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>São Paulo</city>
        <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 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 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/NCT01731639
org study id: MSOME_Grades
nct id: NCT01731639
lead sponsor: 
has dmc: No
A new technique based on the motile sperm organelle morphology examination (MSOME) at a
      magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both
      shape and chromatin content, which is the most important sperm organelle in influencing
      intracytoplasmic sperm injection (ICSI) outcomes.
Sperm morphology has been described as one of the major determinants of male in vitro
      fertility. However, the standard morphology evaluation on random stained cells from the
      ejaculate is of limited value during ICSI. Current research is directed towards the
      dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology
      examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME
      assesses the nucleus, for both shape and chromatin content, which is the most important sperm
      organelle in influencing ICSI outcomes. The goals for this study are to identify whether
      there is a connection between morphologic sperm normalcy under high magnification and (i)
      semen analysis according to the new World Health Organization (WHO) reference values and (ii)
      ICSI outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Pregnancy rates
time frame: 1 month
description: Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed.
measure: Implantation rates
time frame: 1 month
description: Number of gestational sacs divided by the number of transferred embryos.
arm group label: MSOME
arm group type: Experimental
description: The samples will be evaluated under high magnification
intervention type: Other
intervention name: MSOME
description: The semen samples will be evaluated according to the 2010 WHO reference values. After ICSI 200 spermatozoa of each sample will be analyzed under high magnification (MSOME - x6600) and graded into four groups according to the presence or size of the vacuoles. Grade I: normal form and no vacuoles; grade II: normal form and ≤ 2 small vacuoles; grade III: normal form > 2 small vacuoles or at least one large vacuole and grade IV: large vacuole and abnormal head shapes or other abnormalities.
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