Vitamin E and Male Infertility | NCT00178516

Studies
Vitamin E and Male Infertility

NCT00178516

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Jul 30, 2009Estimated

Enrollment

58Actual

Phase

Not provided

Conditions

Male Infertility

Interventions

behavior, procedure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2009

Last Update Posted Date

Jul 30, 2009Estimated

Name	Class
Mae Stone Goode Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

58Actual

Name	Type	Description	Arm Group Labels	Other Names
behavior, procedure	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Infertility clinic, community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivian Lewis, MD	University of Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center, Department of OB/GYN		Rochester	New York	14642	United States

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male
D007246	Infertility

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided