Standardized Laboratory Procedures, Quality Control and Quality Assurance Are Key Requirements for Accurate Semen Analysis in the Evaluation of Infertile Male - Beyond the Abstract

Introduction: Infertility is a significant public health problem that affects 13% to 18% of couples worldwide1 with the male factors either partially or mainly responsible for approximately 50% of the infertility cases.2 Semen analysis is the cornerstone for laboratory evaluation of male infertility and plays a vital role in understanding the cause of infertility.3 As a diagnostic test, conventional semen analysis allows for the detection of absolute cases of male infertility such as azoospermia. In addition, with repeated abnormal semen analyses results, men can be diagnosed as infertile and an approximate prognosis can be given. Furthermore, semen analysis may help predict natural conception and assist the clinicians in managing the couple’s infertility using assisted reproductive technology (ART).4

The reliability and validity of semen analysis depend solely on the expertise and skills of laboratory personnel.5 Hence, frequent training and continuous education and future practitioners in the field of andrology are of great importance to ensure the precision and accuracy of the test results.6 Due to the complexity of the test, and it being done manually on several steps, strict adherence to the semen laboratory manual must be followed to ensure correct results. Laboratory personnel are responsible to ensure the quality of services provided. This is achieved through the establishment of quality control (QC) and quality assurance (QA) plans, which are fundamental to monitor the process rigorously.7


Objectives: In this review, we described the standardized laboratory procedures essential for proper evaluation of semen quality, and the established QC and QA plans in the context of managing the quality of a busy clinical andrology laboratory (see figure below). Additionally, we described several clinical scenarios in which reliable semen analysis results have played a significant role in the management of infertile males.



Infertile Male.jpg 

Recommendations: Understanding the principles and procedures for the analysis of semen plays a major role in clinical practice and the management of infertile patients. In this context, it is essential to enforce strict QC in the andrology laboratories to ensure reproducible results of semen analysis. Participation in proficiency testing for reproductive laboratories engaged in moderate or high complexity testing is necessary by all accrediting agencies. Finally, understanding the reference ranges for normal semen parameters and definitions of various categories of abnormal semen parameters is important in the clinical interpretation of laboratory results.

Written by: Mohamed Arafa, MD, Ramadan Saleh, MD, & Ashok Agarwal, PhD

  1. Department of Urology, Hamad Medical Corporation, Doha, Qatar
  2. Department of Andrology, Sohag University, Egypt,  
  3. American Center for Reproductive Medicine, Cleveland Clinic, Cleveland, OH, USA

References:

  1. Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Hum Reprod. 2017 Sep 1;32(9):1786-1801. doi: 10.1093/humrep/dex234. PMID: 29117321; PMCID: PMC5850297.
  2. Agarwal A, Parekh N, Panner Selvam MK, Henkel R, Shah R, Homa ST, et al. Male Oxidative Stress Infertility (MOSI): Proposed Terminology and Clinical Practice Guidelines for Management of Idiopathic Male Infertility. World J Mens Health. 2019 Sep;37(3):296-312. doi: 10.5534/wjmh.190055. Epub 2019 May 28. PMID: 31081299; PMCID: PMC6704307.
  3. Agarwal A, Baskaran S, Parekh N, Cho CL, Henkel R, Vij S, Arafa M, Panner Selvam MK, Shah R. Male infertility. Lancet. 2021 Jan 23;397(10271):319-333. doi: 10.1016/S0140-6736(20)32667-2. Epub 2020 Dec 10. PMID: 33308486.
  4. Buck Louis GM, Sundaram R, Schisterman EF, Sweeney A, Lynch CD, Kim S, et al. Semen quality and time to pregnancy: the Longitudinal Investigation of Fertility and the Environ- ment Study. Fertil Steril 2014;101:453-62.
  5. Drobnis EZ. Competency assessment in andrology labora- tory. In: Agarwal A, Gupta S, Sharma R, editors. Andrologi- cal evaluation of male infertility: a laboratory guide. Cham: Springer International Publishing; 2016;29-38.
  6. Cairo Consensus Workshop Group. The current status and future of andrology: a consensus report from the Cairo work- shop group. Andrology 2020;8:27-52.
  7. WHO. WHO laboratory manual for the examination and processing of human semen. 5th ed. Geneva: WHO; 2010.

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