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

History of Changes

Purpose

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
DNA Damage Other Complications Associated With Artificial Fertilization


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Non-invasive Method to Assess DNA Damage in Individual Sperm

Further study details as provided by University of South Florida:

Biospecimen Retention: Samples With DNA

sperm


Enrollment:	84
Study Start Date:	October 2008
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Detailed Description:

If you take part in this study,

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.
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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders 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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461395

Locations


United States, Florida
University of South Florida South Tampa Center
Tampa, Florida, United States, 33606

Sponsors and Collaborators

University of South Florida

Investigators


Principal Investigator:	Celso Silva, M.D	University of South Florida

More Information


Responsible Party:	University of South Florida
ClinicalTrials.gov Identifier:	NCT01461395 History of Changes
Other Study ID Numbers:	107209
Study First Received:	February 2, 2011
Last Updated:	August 23, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of South Florida:


IVF

ClinicalTrials.gov processed this record on September 30, 2016

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