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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
DNA Damage Other Complications Associated With Artificial Fertilization

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : October 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
sperm

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
IVF patients already undergoing therapy and providing a semen sample for sperm count
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461395


Locations
Layout table for location information
United States, Florida
University of South Florida South Tampa Center
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
Layout table for investigator information
Principal Investigator: Celso Silva, M.D University of South Florida
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01461395    
Other Study ID Numbers: 107209
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: August 24, 2012
Last Verified: August 2012
Keywords provided by University of South Florida:
IVF