Human sperm survival assay as a bioassay for the assisted reproductive technologies laboratory.

Abstract

CHRISTOPHER J. DE JONGE,* GRACE M.CENTOLA,† MICHAEL L. REED,‡ ROBERT B.SHABANOWITZ,§ STEVE D. SIMON, ANDPATRICK QUINN¶From the *Reproductive Medicine Center, University ofMinnesota, Minneapolis, Minnesota; †AndrologyLaboratory, Department of Obstetrics and Gynecology,University of Rochester Medical Center, Rochester, NewYork; ‡Center for Reproductive Medicine of NewMexico, Albuquerque, New Mexico; §Department ofObstetrics and Gynecology, Geisinger Medical Center,Danville, Pennsylvania; \Office of Medical Research,Children’s Mercy Hospital, Kansas City, Missouri; and¶SAGE BioPharma, San Clemente, California.Recently, Carrell and Cartmill (2002) provided a chro-nology of government oversight and intervention in theprovision of clinical reproductive medicine laboratoryservices. They also outlined the advent and developmentof proficiency testing as a tool by which all clinical an-drology laboratories and in vitro fertilization laboratories(herein collectively referred to as assisted reproductivetechnology [ART] laboratories), are able to assess them-selves internally and externally. In order for ART labo-ratories to be deemed certified, clearly defined objectivesmust be met, including mechanisms for monitoring qual-ity (Clinical Laboratory Improvement Amendments of1988). This progression toward standardized methods formonitoring quality is not unique to the United States. Thesame dedication to ensuring the delivery of quality ARTlaboratory service and care is practiced to varying de-grees throughout the world.