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

DNA Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461395
• Other study ID #: 107209
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: August 23, 2012
• Start date: October 2008
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• DNA Damage
• Other Complications Associated With Artificial Fertilization

Locations

Country	Name	City	State
United States	University of South Florida South Tampa Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States,