Vitamin E and Male Infertility

Male Infertility Clinical Trial

Official title:

Vitamin E and Male Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178516
• Other study ID #: RSRB 10160
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 29, 2009
• Start date: June 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Other:
• behavior, procedure

Locations

Country	Name	City	State
United States	University of Rochester Medical Center, Department of OB/GYN	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Mae Stone Goode Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men			No