The Journal of Urology
Volume 180, Issue 6 , Pages 2569-2576 , December 2008

Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy

  • Kenneth L. Klotz

      Affiliations

    • Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia
    • Financial interest and/or other relationship with ContraVac, Inc.
    • ,
  • Michael A. Coppola

      Affiliations

    • ContraVac, Inc., Charlottesville, Virginia
    • Financial interest and/or other relationship with ContraVac, Inc.
    • ,
  • Michel Labrecque

      Affiliations

    • Université Laval, Quebec, Canada
    • Financial interest and/or other relationship with ContraVac, Inc.
    • ,
  • Victor M. Brugh III

      Affiliations

    • Devine-Tidewater Urology, Virginia Beach, Virginia
    • ,
  • Kim Ramsey

      Affiliations

    • Devine-Tidewater Urology, Virginia Beach, Virginia
    • ,
  • Kyung-ah Kim

      Affiliations

    • Princeton BioMeditech Corp., Princeton, New Jersey
    • ,
  • Mark R. Conaway

      Affiliations

    • Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia
    • ,
  • Stuart S. Howards

      Affiliations

    • Department of Urology, University of Virginia, Charlottesville, Virginia
    • Financial interest and/or other relationship with ContraVac, Inc.
    • ,
  • Charles J. Flickinger

      Affiliations

    • Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia
    • Financial interest and/or other relationship with ContraVac, Inc.
    • ,
  • John C. Herr

      Affiliations

    • Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia
    • Financial interest and/or other relationship with ContraVac, Inc.
    • Corresponding Author InformationCorrespondence: Department of Cell Biology and Center for Contraceptive and Reproductive Health, P.O. Box 800732, University of Virginia Health System, Charlottesville, Virginia 22908-0732

Received 26 March 2008

References 

  1. Alderman PM. General and anomalous sperm disappearance characteristics found in a large vasectomy series. Fertil Steril. 1989;51:859
  2. Barone MA, Nazerali H, Cortes M, Chen-Mok M, Pollack AE, Sokal D. A prospective study of time and number of ejaculations to azoospermia after vasectomy by ligation and excision. J Urol. 2003;170:892
  3. Christensen RE, Maples DC. Postvasectomy semen analysis: are men following up?. J Am Board Fam Pract. 2005;18:44
  4. Maatman TJ, Aldrin L, Carothers GG. Patient noncompliance after vasectomy. Fertil Steril. 1997;68:552
  5. Belker AM, Sexter MS, Sweitzer SJ, Raff MJ. The high rate of noncompliance for post-vasectomy semen examination: medical and legal considerations. J Urol. 1990;144:284
  6. Smucker DR, Mayhew HE, Nordlund DJ, Hahn WK, Palmer KE. Postvasectomy semen analysis: why patients don't follow-up. J Am Board Fam Pract. 1991;4:5
  7. Herr JC, Klotz KL, Anderson P, Adams E, Moore N, Howards SS. Progress in developing an immunochromatographic device for sperm detection. Clin Immunol Newsl. 1999;19:52
  8. Freemerman AJ, Wright RM, Flickinger CJ, Herr JC. Tissue specificity of the acrosomal protein SP-10: a contraceptive vaccine candidate molecule. Biol Reprod. 1994;50:615
  9. Herr JC, Klotz K, Shannon J, Wright RM, Flickinger CJ. Purification and microsequencing of the intra-acrosomal protein SP-10 (Evidence that SP-10 heterogeneity results from endoproteolytic processes). Biol Reprod. 1992;47:11
  10. Herr JC, Flickinger CJ, Homyk M, Klotz K, John E. Biochemical and morphological characterization of the intra-acrosomal antigen SP-10 from human sperm. Biol Reprod. 1990;42:181
  11. Shen M, Wright RM, Carta G, Herr JC. Assay for recombinant and native human intraacrosomal antigen SP-10. Am J Reprod Immunol. 1993;29:231
  12. Smith JC, Cranston D, O'Brien T, Guillebaud J, Hindmarsh J, Turner AG. Fatherhood without apparent spermatozoa after vasectomy. Lancet. 1994;344:30
  13. van Zyl JA, Menkveld R. Oligozoospermia: recent prognosis and the outcome of 73 pregnancies in oligozoospermic couples. Andrologia. 2006;38:87
  14. Turner L, Conway AJ, Jimenez M, Liu PY, Forbes E, McLachlan RI, et al. Contraceptive efficacy of a depot progestin and androgen combination in men. J Clin Endocrinol Metab. 2003;88:4659
  15. Gu YQ, Wang XH, Xu D, Peng L, Cheng LF, Huang MK, et al. A multicenter contraceptive efficacy study of injectable testosterone undecanoate in healthy Chinese men. J Clin Endocrinol Metab. 2003;88:562
  16. Contraceptive efficacy of testosterone-induced azoospermia in normal men (World Health Organization Task Force on methods for the regulation of male fertility). Lancet. 1990;336:955
  17. Contraceptive efficacy of testosterone-induced azoospermia and oligozoospermia in normal men. Fertil Steril. 1996;65:821
  18. Nieschlag E 10th Summit Meeting Group. 10th Summit Meeting consensus: recommendations for regulatory approval for hormonal male contraception. October 22-23, 2006 Contraception. 2007;75:166
  19. De Knijff DW, Vrijhof HJ, Arends J, Janknegt RA. Persistence or reappearance of nonmotile sperm after vasectomy: does it have clinical consequences?. Fertil Steril. 1997;67:332
  20. World Health Organisation. WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction. 4th ed.. Cambridge: Cambridge University Press; 1999;chapt 2, pp 14-17 and chapt 4, p 37
  21. Sperm concentration. In: Manual on Basic Semen Analysis. Nordic Association for Andrology and European Society for Human Reproduction and Embryology 2002; chapt 4, pp 7-13. Available at www.andrology.dk/manual2002.pdf.
  22. Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857

 Study received institutional review board approval.

 Supported by National Institutes of Health Grant U54 29099, Fogarty International Center Grant D43 TW/HD 00654 and research contracts from ContraVac, Inc. (to JCH) with manufacturing and development expenses underwritten by Princeton BioMeditech Corporation.

 For another article on a related topic see page 2706.

PII: S0022-5347(08)02173-3

doi: 10.1016/j.juro.2008.08.045

The Journal of Urology
Volume 180, Issue 6 , Pages 2569-2576 , December 2008

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