USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory


Project Identification:

Project Identifier: LLNL-95-101

Project Title:

Sperm Aneuploidy in Men Carrying Mutations in the Cystic Fibrosis Gene and Who Have Congenital Absence of Vas Deferens

Principle Investigator: 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: January 18, 1995
IRB Approval Number: 95-101

Number of Human Subjects in the Last Reporting Period for this Project: 4
(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 with cystic fibrosis mutations have more chromosomally abnormal sperm than men who do not have the mutation.

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 a cystic fibrosis mutation affecting the development of the vas deferens are identified by a physician in a collaborating medical genetics clinic and the physician arranges for a sperm sample. Samples are frozen. All samples are coded to protect the confidentiality of the donors.

2. There is no known risk to semen donors associated with these sperm analyses.


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