USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-94-105

Project Title:

Investigation of the Relationship between Numerical Chromosomal Aneuploidy in Sperm and Offspring: A Feasibility Study

Principle Investigator: Dr. Andrew J. Wyrobek

Project started in: 1994

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:

Non-DOE Federal: National Institute of Environmental Health Sciences (NIEHS)

Amount: $115,000 (Est.)

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: 94-105

Number of Human Subjects in the Last Reporting Period for this Project: 12
(Reporting periods vary.)

Type of Human Subjects Involvement:

(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 study the relationship between numerical chromosomal abnormalities in semen and the chance of fathering a child with a chromosomal defect (e.g., Klinefelter syndrome, 47,XXY).

b. Methodology:

Blood from the parents and child is used to determine the parental origin of the abnormal chromosome and sperm from the father is used to determine the frequency of aneuploidy in the sperm.

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

None

d. Involvement of Human Subjects.

1. Families who have a child with Klinefelter syndrome are identified. A genetic counselor will approach the family to request participation in our study. The counselor will obtain the questionnaire information and arrange for a visit by a nurse. A nurse will go to the family residence to draw the blood and to pick up the semen sample which was provided by the father. All samples will be coded to protect the identity of the family.

2. There is a small risk to the puncture area associated with drawing blood and a certified nurse will perform this procedure. There are no known risks for the semen donor.