Attachment 10 FACTSHEET HUMAN EXPERIMENTATION - 189 Project Name: The Study of Irradiation Effects on the Human Testis, including Histologic, Chromosomal and Hormonal Aspects Date Started: 8/63 Date Terminated: 12/70 Institution: Battelle Pacific Northwest Laboratory Funding Source(s): AEC Identification: Contract AT(45-1)225, Task Agreement #6 Project Duration: Principal Investigator(s): C. Alvin Paulsen, M.D. Responsible Government Official(s): Charles L. Dunham, M.D. John R. Totter, Ph.D. Objective(s) of Project: 1) To relate radiation dosage to changes in gonadal function, 2) to utilize the radiation gonadal changes as means for studying pituitary-testis interrelationships, 3) to explore therapeutic and medical protective measures with respect to gonadal irradiation, 4) to explore our current concepts concerning radiation dosage expressed in physical terms and ILLEGIBLE relation to biologic effects. Short Description: After appropriate baseline studies were performed, subjects received from 7.5r to 400r x-ray irradiation or sham irradiation to the testis only. Testicular biopsies were performed prior to an up to 6 years post-irradiation to assess changes in the germinal epithelium. Seminal fluid specimens were obtained at two-week intervals throughout the study and were analyzed for morphologic changes and changes in total number of sperm. Urine specimens were obtained monthly for evaluation of hormonal changes. Later, when the techniques were available, serum LH was measured by radioimmunoassay. Studies of ultrastructure changes in testis tissue were performed using electron microscopy. Subjects were followed until hormonal values returned to normal levels and until sperm counts returned to normal ranges. Vasectomies were performed prior to discharge from the study to eliminate the possibility of defective offspring. Only individuals desiring vasectomy were accepted for the study; but in several instances the volunteers changed their mind and did not desire a vasectomy at the conclusion of the study. Subjects were informed in detail regarding the study and signed consent forms were obtained from subjects and from spouses if subjects were married. Subjects were prison inmates only, thus eliminating the possibility of conception during the study. Follow-up Data: (See covering letter) FACTSH..189 (cont'd) References: Attached is the publication list from our final technical report, dated January 31, 1973. Attachment(s): Covering letter; reference list.