USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-90-108

Project Title:

Detection of Aneuploid Human Sperm by In Situ Hybridization and Image Analysis

Principle Investigator: Dr. Andrew J. Wyrobek

Project started in: 1990

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: 90-108

Number of Human Subjects in the Last Reporting Period for this Project: 10
(Reporting periods vary.)

Type of Human Subjects Involvement:

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• Other internal use of chemical substances:

  Medical Therapy

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of existing bodily materials that were collected for another purpose or project.

(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 objectives of this research are to develop new methods for detecting aneuploidy in human sperm using multi-probe fluorescence in situ hybridization (FISH) and image analyses for automation.

b. Methodology:

A small amount of human semen 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:

No person is exposed to these substances for the purpose of our study. Most of the men used in this study are healthy normal men. For validation of our assays, we also utilize a small number of archived semen samples provided by cancer patients before, during and after they have been treated with drug and/or radiation therapies.

d. Involvement of Human Subjects:

1. Men are invited to be volunteers for providing semen samples and some choose to participate in our studies. Samples are delivered to the laboratory and all samples are coded to protect the confidentiality of the donors. Either frozen or fresh samples are used as dictated by the requirements of the specific laboratory methods.

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