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Vitamin E and Male Infertility

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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

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 15, 2005
Last Update Posted Date July 30, 2009
Study Start Date June 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2008)
correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00178516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin E and Male Infertility
Official Title Vitamin E and Male Infertility
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

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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, semen
Sampling Method Non-Probability Sample
Study Population Infertility clinic, community sample
Condition Male Infertility
Intervention Other: behavior, procedure
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2008)
58
Original Enrollment
 (submitted: September 13, 2005)
48
Actual Study Completion Date December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00178516
Other Study ID Numbers RSRB 10160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vivian LEwis, MD, UNiversity of Rochester Medical Center
Study Sponsor University of Rochester
Collaborators Mae Stone Goode Foundation
Investigators
Principal Investigator: Vivian Lewis, MD University of Rochester
PRS Account University of Rochester
Verification Date July 2009