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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01461395
First received: February 2, 2011
Last updated: August 23, 2012
Last verified: August 2012

February 2, 2011
August 23, 2012
October 2008
June 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01461395 on ClinicalTrials.gov Archive Site
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Polscope Sperm: A Non-invasive Method to Assess DNA Damage in Individual Sperm
A Non-invasive Method to Assess DNA Damage in Individual Sperm

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

sperm

Non-Probability Sample

IVF patients already undergoing therapy and providing a semen sample for sperm count

  • DNA Damage
  • Other Complications Associated With Artificial Fertilization
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
June 2012
June 2012   (final data collection date for primary outcome measure)

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

Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01461395
107209
Yes
University of South Florida
University of South Florida
Not Provided
Principal Investigator: Celso Silva, M.D University of South Florida
University of South Florida
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP