NCT00178516

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

September 13, 2005

Last Update Submit

July 29, 2009

Conditions

Male Infertility

Keywords

maleinfertility

Outcome Measures

Primary Outcomes (1)

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

Interventions

behavior, procedureOTHER

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infertility clinic, community sample

You may qualify if:

  • infertile men with previously abnormal semen analyses.
  • Control group: fertile adult males

You may not qualify if:

  • Proxceed use within 3 months of the start of study.
  • Vitamin E supplements with \> 45 IU daily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center, Department of OB/GYN

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, semen

MeSH Terms

Conditions

Infertility, MaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Vivian Lewis, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations

US(1)