Inconsistent Adoption of World Health Organization V (2010) Semen Analysis Reference Ranges in the United States Eight Years After Publication

Urology. 2019 Apr:126:96-101. doi: 10.1016/j.urology.2018.09.041. Epub 2018 Dec 31.

Abstract

Objective: To determine the percentage of laboratories in the United States that have adopted the World Health Organization 2010 (WHO 5) semen analysis (SA) reference values 6years after their publication.

Methods: Laboratories were identified via 3 approaches: using the Clinical Laboratory Improvement Amendments (CLIA) website, the CDC's 2015 Assisted Reproductive Technology Fertility Clinical Success Rate Report, and automated web searches. Laboratories were contacted by phone or email to obtain de-identified SA reports and reference ranges.

Results: We contacted 617 laboratories in 46 states, of which 208 (26.7%) laboratories in 45 states were included in our analysis. 132 (63.5%) laboratories used WHO 5 criteria, 57 (27.4%) used WHO 4 criteria, and 19 (9.1%) used other criteria. WHO 5 criteria adoption rates varied by geographic region, ranging from 87.5% (35/40) in the Midwest to 50.0% (33/66) in the West. There was a greater adoption rate of WHO 5 reference values in academic affiliated (23/26, 88.5%) compared to non-academic affiliated laboratories (110/182, 60.4%) (P = .028).

Conclusion: While the majority of laboratories have adopted WHO 5 criteria following its release 6years ago, a large percentage (36.5%) use what is now considered outdated criteria. This variability could result in the characterization of a male's semen values as being "within reference range" at one center and "outside of reference range" at another. This inconsistency in classification may result in confusion for the both patient and physician and potentially shift the burden of infertility evaluation and treatment to the female partner.

MeSH terms

  • Clinical Laboratory Techniques / standards*
  • Humans
  • Male
  • Publishing
  • Reference Values
  • Semen Analysis* / statistics & numerical data
  • Time Factors
  • United States
  • World Health Organization*