Vitamin E and Male Infertility

July 29, 2009 updated by: University of Rochester

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center, Department of OB/GYN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Infertility clinic, community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Mae Stone Goode Foundation

Investigators

  • Principal Investigator: Vivian Lewis, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2009

Last Update Submitted That Met QC Criteria

July 29, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB 10160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Male Infertility

Clinical Trials on behavior, procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe