Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin E and Male Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00178516
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 30, 2009
Sponsor:
Collaborator:
Mae Stone Goode Foundation
Information provided by:
University of Rochester

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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


Condition or disease Intervention/treatment
Male Infertility Other: behavior, procedure

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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vitamin E and Male Infertility
Study Start Date : June 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin E

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men

Biospecimen Retention:   Samples With DNA
whole blood, serum, semen

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178516


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Vivian Lewis, MD University of Rochester
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Vivian LEwis, MD, UNiversity of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00178516    
Other Study ID Numbers: RSRB 10160
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009
Keywords provided by University of Rochester:
male
infertility
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Infertility, Male