xml: <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/NCT05966883</url>
    </required_header>
    <id_info>
      <org_study_id>SPOT001</org_study_id>
      <nct_id>NCT05966883</nct_id>
    </id_info>
    <brief_title>SpermQT Prospective Observational Trial</brief_title>
    <acronym>SPOT</acronym>
    <official_title>SpermQT Prospective Observational Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inherent Biosciences</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Boston IVF</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shady Grove Fertility</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Brigham Young University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Male Fertility and Sexual Medicine Specialists</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Inherent Biosciences</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 goal of the study is to validate the ability of the Epigenetic Sperm Quality Test&#xD;
        (SpermQT) to assess a man's sperm quality and corresponding success of infertility&#xD;
        treatments.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This prospective study will consist of analyzing a man's semen sample to determine the&#xD;
        patient's SpermQT score and following the success of each fertility treatment to produce a&#xD;
        pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)</measure>
      <time_frame>6 months</time_frame>
      <description>Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)</measure>
      <time_frame>18 months</time_frame>
      <description>Number of patients that have and have not achieved pregnancy during subsequent rounds of IUI and with IVF in each bracket of SpermQT score (Poor, Normal, and Excellent)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients that have and have not achieved a live birth</measure>
      <time_frame>18 months</time_frame>
      <description>Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Male Infertility</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Semen sample&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Couples that are eligible for an IUI procedure and/or have been recommended to pursue IUI,&#xD;
          and/or couples have recently completed an IUI cycle (no matter the outcome)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subjects have been recommended to pursue IUI, or they have recently completed an&#xD;
               IUI (regardless of outcome)&#xD;
  &#xD;
            -  Male partner is under 45 years of age&#xD;
  &#xD;
            -  Female partner is under 38 years of age&#xD;
  &#xD;
            -  The total motile sperm count from the raw semen analysis must be greater than or equal&#xD;
               to 10 million&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The female or male partner have a BMI equal to or greater than 40&#xD;
  &#xD;
            -  The male partner has undergone male testosterone replacement therapy in the last 6&#xD;
               months&#xD;
  &#xD;
            -  Either the female or male partner have a history of recurrent pregnancy loss, defined&#xD;
               as 2 or more consecutive clinical/ultrasound pregnancy losses&#xD;
  &#xD;
            -  There are any known factors contributing to female factor infertility, such as but not&#xD;
               limited to:&#xD;
  &#xD;
            -  Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)&#xD;
  &#xD;
            -  Multiple uterine fibroids 5cm or larger&#xD;
  &#xD;
            -  Severe Asherman's Syndrome&#xD;
  &#xD;
            -  Severe Mullerian anomaly&#xD;
  &#xD;
            -  Lack of tubal patency in at least one fallopian tubes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Kristin Brogaard, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Inherent Biosciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristin Brogaard, PhD</last_name>
      <phone>760-815-8706</phone>
      <email>kristin@inherentbio.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lorry Schneider, BS</last_name>
      <phone>808-286-6564</phone>
      <email>lorry@inherentbio.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Male Fertility and Sexual Medicine Specialists</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92120</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mel Cohen</last_name>
        <phone>619-286-3520</phone>
        <email>mel@fertilityctr.com</email>
      </contact>
      <contact_backup>
        <last_name>Monika Sullivan</last_name>
        <phone>(619) 286-3520</phone>
        <email>monika@fertilityctr.com</email>
      </contact_backup>
      <investigator>
        <last_name>Martin Bastuba, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Shady Grove Fertility</name>
        <address>
          <city>Greenwood Village</city>
          <state>Colorado</state>
          <zip>80111</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cassandra Roeca, MD</last_name>
        <phone>720-704-8221</phone>
        <email>Cassandra.Roeca@sgfertility.com</email>
      </contact>
      <investigator>
        <last_name>Cassandra Roeca, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yale Medicine</name>
        <address>
          <city>Orange</city>
          <state>Connecticut</state>
          <zip>06477</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emre Seli, MD</last_name>
        <phone>877-925-3637</phone>
        <email>emre.seli@yale.edu</email>
      </contact>
      <contact_backup>
        <last_name>Ahmet Ayaz, PhD</last_name>
        <phone>877-925-3637</phone>
        <email>ahmet.ayaz@yale.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Emre Seli, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Boston IVF</name>
        <address>
          <city>Waltham</city>
          <state>Massachusetts</state>
          <zip>02451</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Denny Sakkas, PhD</last_name>
        <phone>781-434-6500</phone>
        <email>dsakkas@bostonivf.com</email>
      </contact>
      <contact_backup>
        <last_name>Kristin Rooney</last_name>
        <phone>781-434-6500</phone>
        <email>krooney@bostonivf.com</email>
      </contact_backup>
      <investigator>
        <last_name>Denny Sakkas, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98105</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Charles Muller, PhD</last_name>
        <phone>206-598-1018</phone>
        <email>cmuller@uw.edu</email>
      </contact>
      <contact_backup>
        <last_name>Lila Graham, PhD</last_name>
        <phone>206-543-4671</phone>
        <email>lg8@uw.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Charles Muller, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Epigenetics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
      <mesh_term>Infertility, Male</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966883
  org study id: SPOT001
  nct id: NCT05966883
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test
        (SpermQT) to assess a man's sperm quality and corresponding success of infertility
        treatments.
  This prospective study will consist of analyzing a man's semen sample to determine the
        patient's SpermQT score and following the success of each fertility treatment to produce a
        pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.
  observational model: Case-Only
  time perspective: Prospective
  measure: Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)
  time frame: 6 months
  description: Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent)
  measure: Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)
  time frame: 18 months
  description: Number of patients that have and have not achieved pregnancy during subsequent rounds of IUI and with IVF in each bracket of SpermQT score (Poor, Normal, and Excellent)
  measure: Number of patients that have and have not achieved a live birth
  time frame: 18 months
  description: Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent)
  Semen sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  last name: Kristin Brogaard, PhD
  role: Principal Investigator
  affiliation: Inherent Biosciences
  last name: Kristin Brogaard, PhD
  phone: 760-815-8706
  email: kristin@inherentbio.com
  last name: Lorry Schneider, BS
  phone: 808-286-6564
  email: lorry@inherentbio.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Infertility
  mesh term: Infertility, Male
  sharing ipd: No