Vitamin E and Male Infertility
This study has been completed.
Sponsor:
University of Rochester
Collaborator:
Mae Stone Goode Foundation
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178516
First received: September 13, 2005
Last updated: July 29, 2009
Last verified: July 2009
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Purpose
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 | Intervention |
|---|---|
|
Male Infertility |
Other: behavior, procedure |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Vitamin E and Male Infertility |
Resource links provided by NLM:
Genetics Home Reference related topics:
CATSPER1-related nonsyndromic male infertility
Y chromosome infertility
sensorineural deafness and male infertility
Drug Information available for:
alpha-Tocopherol
Tocopherol
alpha-Tocopherol succinate
Tocopherol acetate
DL-alpha-Tocopherol
U.S. FDA Resources
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, serum, semen
| Enrollment: | 58 |
| Study Start Date: | June 2004 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178516
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178516
Locations
| 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
| Principal Investigator: | Vivian Lewis, MD | University of Rochester |
More Information
| Responsible Party: | Vivian LEwis, MD, UNiversity of Rochester Medical Center |
| ClinicalTrials.gov Identifier: | NCT00178516 History of Changes |
| Other Study ID Numbers: | RSRB 10160 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Rochester:
|
male infertility |
Additional relevant MeSH terms:
|
Infertility Infertility, Male Genital Diseases, Male Genital Diseases, Female Vitamins Vitamin E Tocopherols Tocotrienols |
Alpha-Tocopherol Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on September 29, 2016