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

• ClinicalTrials.gov Identifier: NCT01461395
• Recruitment Status: Completed
• First Posted: October 28, 2011
• Last Update Posted: August 24, 2012
• Sponsor: University of South Florida
• 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
• 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

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

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