Vitamin E and Male Infertility

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

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Rochester Medical Center, Department of OB/GYN

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavior, procedure

Other

Primary outcomes

correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

Mae Stone Goode Foundation

Registry information

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 15, 2005
Registry last updated: Jul 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed