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Polscope Sperm: A Non-invasive Method to Assess DNA Damage in Individual Sperm

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01461395
Collaborator
(none)
84
Enrollment
1
Location
44
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find a non-invasive way to discover DNA (deoxyribonucleic acid, which is the genetic material inside your cells) alterations in the sperm's head, in the near future leading us to choose the "good sperm" in a simplified manner. This could then increase chances of a successful in-vitro fertilization (IVF) treatment when there are sperm abnormalities.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    If you take part in this study,

    1. Your physician is asking you to provide a semen sample as you already would. The sample will be taken to the IVF lab which would occur if you were not involved in this research. The part that would be thrown away is then further analyzed under a polarized light microscope. The sample is exposed to ultraviolet (UV) light for a period of 20 minutes after which it is analyzed under the microscope again, looking for any changes when compared the sample that was not exposed to UV light. The sample is then discarded.

    2. Your name will be removed from the sample after the regular semen analysis is done; therefore there will be no way of associating the research results with you. No information will be needed from you and you will not be contacted in the future regarding this research.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    84 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Non-invasive Method to Assess DNA Damage in Individual Sperm
    Study Start Date :
    Oct 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 60 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • Age 18-60 years

      • provide informed consent

      • Already providing a semen sample as routine therapy in IVF

      Exclusion Criteria:

      -unable to provide informed consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of South Florida South Tampa Center Tampa Florida United States 33606

      Sponsors and Collaborators

      • University of South Florida

      Investigators

      • Principal Investigator: Celso Silva, M.D, University of South Florida

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of South Florida
      ClinicalTrials.gov Identifier:
      NCT01461395
      Other Study ID Numbers:
      • 107209
      First Posted:
      Oct 28, 2011
      Last Update Posted:
      Aug 24, 2012
      Last Verified:
      Aug 1, 2012
      Keywords provided by University of South Florida
      IVF

      Study Results

      No Results Posted as of Aug 24, 2012