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Vitamin E and Male Infertility

This study has been completed.
Sponsor:
Collaborator:
Mae Stone Goode Foundation
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178516
First received: September 13, 2005
Last updated: July 29, 2009
Last verified: July 2009
History of Changes
  Purpose

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


Condition Intervention
Male Infertility
 Other: behavior, procedure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vitamin E and Male Infertility

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, semen
Enrollment: 58
Study Start Date: June 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infertility clinic, community sample

Criteria

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
  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: NCT00178516

Locations
United States, New York
University of Rochester Medical Center, Department of OB/GYN
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Mae Stone Goode Foundation
Investigators
Principal Investigator: Vivian Lewis, MD University of Rochester
  More Information

No publications provided

Responsible Party: Vivian LEwis, MD, UNiversity of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00178516     History of Changes
Other Study ID Numbers: RSRB 10160
Study First Received: September 13, 2005
Last Updated: July 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
male
infertility

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on March 03, 2015