Ten years’ experience with an external quality control program for semen analysis

Capsule:
Voluntary participation in this external quality control program improved overall performance of semen analysis. Surprisingly,

Authors:
Con Mallidis, Ph.D., Trevor G. Cooper, Ph.D., Barbara Hellenkemper, M.T.A., Martin Lablans, Ph.D., Frank Ückert, Ph.D., Eberhard Nieschlag, M.D., Ph.D.

Volume 98, Issue 3, Pages 611-616.e4, September 2012

Abstract:

Objective:
To gauge the performance of laboratories and impact of the German semen analysis external quality control program (QuaDeGA) over its first 10 years.

Design:
Retrospective analysis of QuaDeGA’s twice yearly distribution of fixed semen samples and electronic material documenting sperm motility. Ranking of each participant’s responses was determined according to their relation to a “target window.”

Setting:
Multicenter

Patients:
Healthy donors.

Intervention:
None.

Outcome Measurements:
Laboratory performance, World Health Organization (WHO) adherence

Results:
Over 19 runs, there was a steady increase of participants (280 laboratories), largest group being private urological practices. Although use of WHO recommended Neubauer chamber (33% – 55%) and diluent (11% – 32%) increased, the opposite occurred with morphology staining protocols (41% – 19%). In toto, less than 8% of laboratories truly followed WHO guidelines. Median-based comparisons, replacing reference laboratories, resulted in a merging of performance rankings regardless of the protocols employed.

Conclusions:
Adherence to WHO recommendations is low with the majority of laboratories employing methods expressly opposed by the guidelines. Participation in QuaDeGA was found to improve the performance of the laboratories involved in the program. However, the use of median based ranking while decreasing the extent of variance between laboratories brings into question the significance of the rankings.

  • eykko

    I agree with the previous poster: the current techniques employed are very subjective and depend heavily on the eye of the technician performing the examination. Unfortunately, many non fertility labs are performing these tests and providing inferior results that we subsequently use to guide our management of our patients. If standards are to be set forth, they need to be adhered to. Less than 10% of my current semen analyses that I get from outside labs even adhere to the WHO 2010 guidelines for reporting.

    The real question we all must ask is what makes up a “normal” semen analysis? I see men with “normal” bulk parameters
    that cannot cause a pregnancy with a normal female partner. Yet, I also
    have men who have caused a pregnancy after a vasectomy when their
    counts and <100,000 per mL.

  • Mike Hsieh

    Another article adding to the existing evidence of high variability between andrology labs. Until we have an objective method of analyzing semen sample(?improved automated system), male infertility specialists still have to interpret the available semen analysis with caution.

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