<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/NCT01683435</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 11-134</org_study_id>
    <nct_id>NCT01683435</nct_id>
  </id_info>
  <brief_title>The Value of HBA in the Evaluation of Idiopathic Infertility</brief_title>
  <official_title>The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's-Roosevelt Hospital Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Luke's-Roosevelt Hospital Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We would like to determine if HBA® testing of sperm in couples with presumed idiopathic&#xD;
      infertility will reveal lower binding percentages than in couples with an identifiable cause&#xD;
      of infertility either male factor or tubal factor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We would like to determine if HBA® testing of sperm in couples with presumed idiopathic&#xD;
      infertility will reveal lower binding percentages than in couples with an identifiable cause&#xD;
      of infertility either male factor or tubal factor We would like to determine if patients with&#xD;
      abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate,&#xD;
      implantation rate, and increased miscarriage rate&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In each of these groups we will assess presence of HBA bound sperm</measure>
    <time_frame>immediate at time of preforming HBA test</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>hylauronin binding assay</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HBA binding assay</intervention_name>
    <description>HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.</description>
    <arm_group_label>hylauronin binding assay</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  . All groups will include females under 40 years of age undergoing 1st IVF cycle 3&#xD;
             groups&#xD;
&#xD;
               1. Abnormal Semen Analysis (sperm count &lt;10 million/ml and /or rapid progressive&#xD;
                  motility &lt; 50 %, WHO morphology &lt;30%) normal HSG , normal ovarian reserve testing&#xD;
                  and ovulation testing&#xD;
&#xD;
               2. Unexplained infertility- normal ovarian reserve testing and ovulation testing&#xD;
                  (FSH&lt; 10, AMH&gt;1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal&#xD;
                  tubes on HSG or Laparoscopy&#xD;
&#xD;
               3. Tubal infertility as assessed by HSG or laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women over 40, prior failed IVF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Keltz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai St. Luke's</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Continuum Reproductive Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>August 31, 2015</last_update_submitted>
  <last_update_submitted_qc>August 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01683435
org study id: IRB 11-134
nct id: NCT01683435
lead sponsor: 
has dmc: No
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic
      infertility will reveal lower binding percentages than in couples with an identifiable cause
      of infertility either male factor or tubal factor
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic
      infertility will reveal lower binding percentages than in couples with an identifiable cause
      of infertility either male factor or tubal factor We would like to determine if patients with
      abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate,
      implantation rate, and increased miscarriage rate
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: In each of these groups we will assess presence of HBA bound sperm
time frame: immediate at time of preforming HBA test
arm group label: hylauronin binding assay
arm group type: Experimental
description: HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
intervention type: Other
intervention name: HBA binding assay
description: HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
arm group label: hylauronin binding assay
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Martin Keltz, MD
role: Principal Investigator
affiliation: Mount Sinai St. Luke's
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infertility