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/NCT05999591</url>
    </required_header>
    <id_info>
      <org_study_id>OBGY-202308.01</org_study_id>
      <nct_id>NCT05999591</nct_id>
    </id_info>
    <brief_title>Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination</brief_title>
    <official_title>Effect of Post-Wash Total Motile Sperm Count on the Pregnancy Rate of Infertility Patients Undergoing Intrauterine Insemination</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Padjadjaran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitas Padjadjaran</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>
        Intrauterine insemination (IUI) is one of the most important infertility treatments.&#xD;
        Infertility is failure to establish pregnancy (&gt;12 months) with regularly unprotected sexual&#xD;
        intercourse. Post-wash total motile sperm count (TMSC) vaguely defined as a predictor of IUI&#xD;
        pregnancy rate. The minimum value required is also not clear. This study aimed to further&#xD;
        define the relationship and determine the minimum recommended value to achieve a satisfactory&#xD;
        IUI pregnancy rate.&#xD;
  &#xD;
        Post-wash TMSC is predictive of IUI success. No optimal cut-off could be identified. In&#xD;
        conclusion, post-wash TMSC is highly suggested as a quantitative predictor along with others&#xD;
        in counseling and informed consent. The recommended threshold value is &gt;3 x 106.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 30, 2022</start_date>
    <completion_date type="Actual">January 22, 2023</completion_date>
    <primary_completion_date type="Actual">December 10, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pregnancy rate</measure>
      <time_frame>max 9 months</time_frame>
      <description>Pregnancy number divided by number of IUI cycles</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">330</enrollment>
    <condition>Insemination</condition>
    <arm_group>
      <arm_group_label>Intrauterine insemination</arm_group_label>
      <description>Patients undergoing intrauterine insemination</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intrauterine insemination</intervention_name>
      <description>Transfer of sperm into the fallopian tube through a specialised cannula</description>
      <arm_group_label>Intrauterine insemination</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A group of patients undergoing intrauterine insemination for various causes of infertility&#xD;
          at a tertiary fertility clinic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  post-wash total motile sperm count needed to be over 5 x 10^5&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  missing data on pregnancy outcome and missing medical records&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hanom H Syam, M.D., Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Padjadjaran Bandung</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran</name>
        <address>
          <city>Bandung</city>
          <state>Jawa Barat</state>
          <zip>40161</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <results_reference>
      <citation>Miller DC, Hollenbeck BK, Smith GD, Randolph JF, Christman GM, Smith YR, Lebovic DI, Ohl DA. Processed total motile sperm count correlates with pregnancy outcome after intrauterine insemination. Urology. 2002 Sep;60(3):497-501. doi: 10.1016/s0090-4295(02)01773-9.</citation>
      <PMID>12350496</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>infertility</keyword>
    <keyword>intrauterine insemination</keyword>
    <keyword>post-wash total motile sperm count</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>anonymised patient data are available upon reasonable written request to the authors</ipd_description>
    </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/NCT05999591
  org study id: OBGY-202308.01
  nct id: NCT05999591
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Intrauterine insemination (IUI) is one of the most important infertility treatments.
        Infertility is failure to establish pregnancy (>12 months) with regularly unprotected sexual
        intercourse. Post-wash total motile sperm count (TMSC) vaguely defined as a predictor of IUI
        pregnancy rate. The minimum value required is also not clear. This study aimed to further
        define the relationship and determine the minimum recommended value to achieve a satisfactory
        IUI pregnancy rate.
  
        Post-wash TMSC is predictive of IUI success. No optimal cut-off could be identified. In
        conclusion, post-wash TMSC is highly suggested as a quantitative predictor along with others
        in counseling and informed consent. The recommended threshold value is >3 x 106.
  observational model: Cohort
  time perspective: Retrospective
  measure: Pregnancy rate
  time frame: max 9 months
  description: Pregnancy number divided by number of IUI cycles
  arm group label: Intrauterine insemination
  description: Patients undergoing intrauterine insemination
  intervention type: Procedure
  intervention name: Intrauterine insemination
  description: Transfer of sperm into the fallopian tube through a specialised cannula
  arm group label: Intrauterine insemination
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Hanom H Syam, M.D., Ph.D
  role: Principal Investigator
  affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Padjadjaran Bandung
  facility: 
  country: Indonesia
  citation: Miller DC, Hollenbeck BK, Smith GD, Randolph JF, Christman GM, Smith YR, Lebovic DI, Ohl DA. Processed total motile sperm count correlates with pregnancy outcome after intrauterine insemination. Urology. 2002 Sep;60(3):497-501. doi: 10.1016/s0090-4295(02)01773-9.
  PMID: 12350496
  responsible party type: Sponsor
  mesh term: Infertility
  sharing ipd: No
  ipd description: anonymised patient data are available upon reasonable written request to the authors