<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/NCT01729533</url>
  </required_header>
  <id_info>
    <org_study_id>IMSI_unexplained infertility</org_study_id>
    <nct_id>NCT01729533</nct_id>
  </id_info>
  <brief_title>The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility</brief_title>
  <official_title>The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility</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>
      The (motile sperm organelle morphology examination) MSOME allows the detection of sperm&#xD;
      vacuoles that seems to be related to sperm DNA damage.&#xD;
&#xD;
      The investigators hypothesized that couples with unexplained infertility could benefit from&#xD;
      the injection of spermatozoa selected under high-magnification (x6600)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When routine infertility workup yields normal results in both partners, the couple is defined&#xD;
      as suffering from unexplained infertility. These couples present normal semen analysis.&#xD;
&#xD;
      It has been reported that even infertile patients with normozoospermic parameters can have&#xD;
      higher values of DNA damage than fertile controls.&#xD;
&#xD;
      It has been proposed that the use of ''invisible damaged'' spermatozoa could result in&#xD;
      fertilization failure, impaired normal embryo development, reduced implantation and pregnancy&#xD;
      rates.&#xD;
&#xD;
      The motile sperm organelle morphology examination (MSOME) allows the detection of sperm&#xD;
      vacuoles that seems to be related to sperm DNA damage.&#xD;
&#xD;
      The investigators hypothesized that couples with unexplained infertility could benefit from&#xD;
      the injection of spermatozoa selected under high-magnification (x6600)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</primary_completion_date>
  <phase>N/A</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>1 month</time_frame>
    <description>Number of pregnancies divided by the number of cycles with embryo transfer</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>ICSI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, patients will be provided with standard intracytoplasmic sperm injection (ICSI), in which sperm selection is performed under an overall magnification of x400.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMSI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, patients will be provided with a modified intracytoplasmic sperm injection (ICSI) procedure, the IMSI, in which sperm selection is performed under an overall magnification of x6600.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ICSI</intervention_name>
    <description>ICSI Sperm selection in the ICSI group is analyzed under a magnification of 400x using an inverted microscope. ICSI is performed in a micro-injection dish prepared with 4 µL droplets of buffered medium and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.</description>
    <arm_group_label>ICSI</arm_group_label>
    <other_name>Intracytoplasmic sperm injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IMSI</intervention_name>
    <description>Sperm selection in the IMSI group is analyzed at high magnification using an inverted microscope equipped with high-power differential interference contrast optics. The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei ([1] smooth, [2] symmetric, and [3] oval configuration) and [4] normal nuclear chromatin content (if it contained no more than one vacuole, which occupies &lt;4% of the nuclear area) are selected for injection.</description>
    <arm_group_label>IMSI</arm_group_label>
    <other_name>Intracytoplasmic morphologically selected sperm injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women of good physical and mental health&#xD;
&#xD;
          -  Undergoing assisted reproduction as a result of 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;
          -  Men with abnormal semen parameters according to the 2010 WHO values&#xD;
&#xD;
          -  Women with polycystic ovaries&#xD;
&#xD;
          -  Women with endometriosis&#xD;
&#xD;
          -  Women with gynaecological/medical disorders&#xD;
&#xD;
          -  Women or men with a positive result for sexually transmitted diseases&#xD;
&#xD;
          -  Women who had received hormone therapy for at least 60 days preceding the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sapientiae Institute</name>
      <address>
        <city>São Paulo</city>
        <zip>04503040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 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>
  <keyword>ICSI</keyword>
  <keyword>IMSI</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Sperm morphology</keyword>
  <keyword>Unexplained infertility</keyword>
  <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/NCT01729533
org study id: IMSI_unexplained infertility
nct id: NCT01729533
lead sponsor: 
has dmc: No
The (motile sperm organelle morphology examination) MSOME allows the detection of sperm
      vacuoles that seems to be related to sperm DNA damage.

      The investigators hypothesized that couples with unexplained infertility could benefit from
      the injection of spermatozoa selected under high-magnification (x6600)
When routine infertility workup yields normal results in both partners, the couple is defined
      as suffering from unexplained infertility. These couples present normal semen analysis.

      It has been reported that even infertile patients with normozoospermic parameters can have
      higher values of DNA damage than fertile controls.

      It has been proposed that the use of ''invisible damaged'' spermatozoa could result in
      fertilization failure, impaired normal embryo development, reduced implantation and pregnancy
      rates.

      The motile sperm organelle morphology examination (MSOME) allows the detection of sperm
      vacuoles that seems to be related to sperm DNA damage.

      The investigators hypothesized that couples with unexplained infertility could benefit from
      the injection of spermatozoa selected under high-magnification (x6600)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pregnancy rate
time frame: 1 month
description: Number of pregnancies divided by the number of cycles with embryo transfer
arm group label: ICSI
arm group type: Active Comparator
description: In this arm, patients will be provided with standard intracytoplasmic sperm injection (ICSI), in which sperm selection is performed under an overall magnification of x400.
arm group label: IMSI
arm group type: Experimental
description: In this arm, patients will be provided with a modified intracytoplasmic sperm injection (ICSI) procedure, the IMSI, in which sperm selection is performed under an overall magnification of x6600.
intervention type: Other
intervention name: ICSI
description: ICSI Sperm selection in the ICSI group is analyzed under a magnification of 400x using an inverted microscope. ICSI is performed in a micro-injection dish prepared with 4 µL droplets of buffered medium and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.
arm group label: ICSI
other name: Intracytoplasmic sperm injection
intervention type: Other
intervention name: IMSI
description: Sperm selection in the IMSI group is analyzed at high magnification using an inverted microscope equipped with high-power differential interference contrast optics. The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei ([1] smooth, [2] symmetric, and [3] oval configuration) and [4] normal nuclear chromatin content (if it contained no more than one vacuole, which occupies <4% of the nuclear area) are selected for injection.
arm group label: IMSI
other name: Intracytoplasmic morphologically selected sperm injection
criteria: 
gender: Female
minimum age: N/A
maximum age: 36 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Infertility