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

NCT ID: NCT01461395

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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DNA Damage Other Complications Associated With Artificial Fertilization

Keywords

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IVF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celso Silva, M.D

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida South Tampa Center

Tampa, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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107209

Identifier Type: -

Identifier Source: org_study_id