USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory


Project Identification:

Project Identifier: LLNL-95-111

Project Title:

Detection of Chromosomal Abnormalities in Sperm from Men Carrying Specific Constitutive Chromosomal Genetic Factors

Principle Investigator: Dr. Andrew J. Wyrobek

Project started in: 1995


Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)
Amount: $70,000 (Est.)
Comments:
This is one third of a $210,000 project.


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: March 22, 1995
IRB Approval Number: 95-111

Number of Human Subjects in the Last Reporting Period for this Project: 1
(Reporting periods vary.)

Type of Human Subjects Involvement:

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

a. Objectives:

The objective of this study is to determine whether men who carry chromosomal abnormalities produce higher rates of chromosomally abnormal sperm than do chromosomally normal men.

b. Methodology:

A small amount of sperm is smeared onto glass slides and is analyzed for sperm aneuploidy by fluorescence in situ hybridization (FISH) using chromosome specific DNA probes.

c. Ionizing Radiation, Radioactive Substances, or Chemical Substances.

None

d. Involvement of Human Subjects.

1. Men who carry chromosomal abnormalities are identified by a collaborating physician in a medical genetics clinic and the doctor arranges for the sperm samples. Samples are delivered to the laboratory and frozen. All samples are coded to protect the confidentiality of the donors.

2. There is no known risk to the semen donors.


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