Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461395
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : August 24, 2012
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date February 2, 2011
First Posted Date October 28, 2011
Last Update Posted Date August 24, 2012
Study Start Date October 2008
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Polscope Sperm: A Non-invasive Method to Assess DNA Damage in Individual Sperm
Official Title A Non-invasive Method to Assess DNA Damage in Individual Sperm
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
sperm
Sampling Method Non-Probability Sample
Study Population IVF patients already undergoing therapy and providing a semen sample for sperm count
Condition
  • DNA Damage
  • Other Complications Associated With Artificial Fertilization
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 23, 2012)
84
Original Estimated Enrollment
 (submitted: October 27, 2011)
100
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01461395
Other Study ID Numbers 107209
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of South Florida
Study Sponsor University of South Florida
Collaborators Not Provided
Investigators
Principal Investigator: Celso Silva, M.D University of South Florida
PRS Account University of South Florida
Verification Date August 2012