<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/NCT02971280</url>
  </required_header>
  <id_info>
    <org_study_id>0008-16-RMB</org_study_id>
    <nct_id>NCT02971280</nct_id>
  </id_info>
  <brief_title>Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exposure to heavy metals may interfere with basic cellular functions, including DNA&#xD;
      synthesis.&#xD;
&#xD;
      The aim of the study is to correlate heavy metals concentration in body fluids of&#xD;
      reproductive importance and IVF outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular&#xD;
      fluid of IVF patients.&#xD;
&#xD;
      Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor&#xD;
      ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis&#xD;
      patients. Normal sperm count. Heavy metals concentrations will be measured using atomic&#xD;
      absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes&#xD;
      obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">November 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Live birth rate (&quot;take-home baby&quot;)</measure>
    <time_frame>9 months from embryo transfer</time_frame>
    <description>IVF cycle resulting in pregnancy that ends in a live birth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>1 month from embryo transfer</time_frame>
    <description>Gestational sac(s) seen by ultrasound 1 month after embryo transfer.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fertilization in Vitro</condition>
  <eligibility>
    <study_pop>
      <textblock>
        IVF patients (women and men)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age of female patients: &lt;=39&#xD;
&#xD;
          -  Age of male patients: 18-50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Alcohol/drug abuse&#xD;
&#xD;
          -  Long-term/chronic medications&#xD;
&#xD;
          -  Severe health/mental problems&#xD;
&#xD;
          -  Dental or other transplants&#xD;
&#xD;
          -  Fragile X mutations&#xD;
&#xD;
          -  Fertility preservation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shahar Kol, MD</last_name>
    <phone>97247773232</phone>
    <email>skol@rambam.health.gov.il</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Shahar Kol MD</investigator_full_name>
    <investigator_title>Director IVF Unit, principal investigator, Assistant clinical Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be published in scientific journal. Individual researchers will have access to source data anonymously.</ipd_description>
  </patient_data>
  <!-- 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/NCT02971280
org study id: 0008-16-RMB
nct id: NCT02971280
lead sponsor: 
has dmc: No
Exposure to heavy metals may interfere with basic cellular functions, including DNA
      synthesis.

      The aim of the study is to correlate heavy metals concentration in body fluids of
      reproductive importance and IVF outcome.
Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular
      fluid of IVF patients.

      Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor
      ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis
      patients. Normal sperm count. Heavy metals concentrations will be measured using atomic
      absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes
      obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.
observational model: Cohort
time perspective: Prospective
measure: Live birth rate ("take-home baby")
time frame: 9 months from embryo transfer
description: IVF cycle resulting in pregnancy that ends in a live birth.
measure: Clinical pregnancy rate
time frame: 1 month from embryo transfer
description: Gestational sac(s) seen by ultrasound 1 month after embryo transfer.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Shahar Kol, MD
phone: 97247773232
email: skol@rambam.health.gov.il
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Shahar Kol MD
investigator title: Director IVF Unit, principal investigator, Assistant clinical Professor
sharing ipd: No
ipd description: Data will be published in scientific journal. Individual researchers will have access to source data anonymously.