Introduction

There is no universal agreement on normal reference ranges for semen analysis (SA). Many laboratories use the World Health Organization (WHO) reference ranges, however the newest 2010 edition (WHO 5) is not without controversy. It is unknown how many laboratories utilize WHO 5 values now six years after their release. Our objective was to determine rates of adoption of WHO 5 criteria among US andrology labs. Variable reference range adoption leads to different categorization of results as "normal" or "abnormal" depending on where men obtain their SA._x000D_

Methods

Clinical Laboratory Improvement Amendments (CLIA) laboratories certified to perform SA were extracted from CLIA (http://www.cdc.gov/clia/Resources/Laboratoriesearch.aspx) using a keyword search with: "andrology," "infertility," and "semen analysis." De-identified SA reports and reference ranges used were obtained by phone or email. Rates of adoption were computed by comparing reported values to WHO criteria. A chi-square test was used to compare the rate of WHO 5 criteria adoption between academic and non-academic centers._x000D_

Results

We contacted 280 laboratories in 46 states. A total of 132 laboratories responded, with 104 (79%) laboratories performing SA in 32 states. Among labs performing SA, WHO 5 criteria was utilized by 63 (61%), while 29 (28%) used WHO 4 criteria. 12 (12%) laboratories used modified WHO criteria. WHO 5 criteria adoption was higher among academic centers (n=14, 86%) compared to non-academic centers (n=90, 57%) (P=0.04). Adoption rates varied by geographic region, ranging from 94% (16/17) in the Midwest to just 42% (11/26) in the West.

Conclusions

While the majority of laboratories have adopted WHO 5 criteria, a large percentage (39%) still use other criteria six years after the WHO 5 criteria were released. This variability could result in a male patient being characterized as "fertile" in one center and "subfertile" in another. The lack of consensus amongst laboratories in SA reference ranges could thus substantially impact management of the patient and his partner depending on where they seek treatment. _x000D_

Funding

None