Vitamin E and Male Infertility

NCT ID: NCT00178516

Last Updated: 2009-07-30

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

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-12-31

Brief Summary

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The goal of this study is to determine whether there is a correlation between the levels of Vitamin E in sperm and sperm DNA fragmentation.

Previous research has shown that damage to the DNA in sperm may cause infertility or increase the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming majority of sperm). Some studies suggest that DNA damage can be caused by oxidative stress. Antioxidants, such as Vitamin E, which are present in some foods, can prevent damage to cells from "free radicals", which are naturally present by-products of metabolism. We ask whether there is a correlation between sperm DNA damage and Vitamin E

Detailed Description

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Sperm DNA damage is an emerging cause of male infertility that is likely to be more common among men with increased reactive oxygen species in the ejaculate. Vitamin E can protect the sperm membrane from oxidative damage and increased levels are associated with low levels of reactive oxygen species. This is a study of Vitamin E levels in the spermatozoa and sera of 48 infertile men, and 20 fertile men as a control group, to look for correlations between sperm vitamin E levels and the degree of sperm DNA fragmentation. Dietary intake of antioxidants will also be included.

Conditions

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Male Infertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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behavior, procedure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* infertile men with previously abnormal semen analyses.
* Control group: fertile adult males

Exclusion Criteria

* Proxceed use within 3 months of the start of study.
* Vitamin E supplements with \> 45 IU daily
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mae Stone Goode Foundation

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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UNiversity of Rochester Medical Center

Principal Investigators

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Vivian Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester Medical Center, Department of OB/GYN

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RSRB 10160

Identifier Type: -

Identifier Source: org_study_id

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