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A Translational Medicine Appraisal of Specialized Andrology Testing in Unexplained Male Infertility

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A Translational Medicine Appraisal of Specialized Andrology Testing in Unexplained Male Infertility Int Urol Nephrol (2014) 46:1037–1052 DOI 10.1007/s11255-014-0715-0 UROLOGY – REVIEW A translational medicine appraisal of specialized andrology testing in unexplained male infertility Sandro C. Esteves • Rakesh K. Sharma • Jaime Gosa´lvez • Ashok Agarwal Received: 13 March 2014 / Accepted: 5 April 2014 / Published online: 27 April 2014 Ó Springer Science+Business Media Dordrecht 2014 Abstract The diagnostic and prognostic validity of sperm Keywords Andrology Á Male infertility Á Diagnostic function biomarkers is particularly relevant for males with techniques and procedures Á Translational medical unexplained infertility in which routine semen analysis research Á Review fails to detect subcellular sperm dysfunctions. In this general review, we examine the role and significance of specialized andrology laboratory tests from past to present Introduction and provide a glance toward the future. We concluded that the assessment of sperm DNA damage and oxidative stress Male factor is responsible for about 50 % of infertility provide a relatively independent measure of fertility that cases; 20 % as sole reason and 30–40 % as contributory yields diagnostic and prognostic information complemen- [1]. When at least two semen analyses are normal and there tary to, but distinct and more significant than, standard is no identifiable cause after a thorough workup including sperm parameters. Since none of the available methods for history, physical examination and endocrine laboratory such testing have been fully translated, further research is testing, the patients are categorized as having unexplained necessary to evaluate their cost-effectiveness when applied male infertility (UMI) [2]. Female factor infertility should in large scale to daily medical practice. Application of have been ruled out with at least a detailed history and translational medicine concepts would also be useful to clinical examination, and no demonstrable tubal patency, accelerate the clinical application of recent discoveries in uterine anatomy and ovulatory function abnormalities [3]. the fields of genomics, proteomics and metabolomics. The concept of UMI itself has only recently emerged and should be differentiated from idiopathic male infertility (IMI). Both conditions share similar traits but abnormal semen analyses are characteristic of IMI. The reported prevalence of UMI varies widely from 6 to & S. C. Esteves ( ) 27 % [2], thus indicating that the percentage of men suffering Androfert, Andrology and Human Reproduction Clinic, Av. Dr. Heitor Penteado, 1464, Campinas, Sa˜o Paulo 13075-460, Brazil from this condition depends on the extent to which they have e-mail: [email protected] been investigated. Ideally, the patient needs to seek evalua- tion by a specialist for being diagnosed with unexplained R. K. Sharma Á A. Agarwal infertility but in the Western world only about half of infertile Center for Reproductive Medicine, Cleveland Clinic, Cleveland, OH, USA men will present to a specialist for an evaluation [4, 5]. e-mail: [email protected] Economic, social, geographical and religious are important A. Agarwal determinants of whether a man will seek specialist’s evalu- e-mail: [email protected] ation and thus could affect the reported prevalence of UMI. Potential causes that have been associated with the J. Gosa´lvez ‘‘diagnosis’’ of UMI, and which are frequently unexplored, Genetics Unit, Department of Biology, Universidad Auto´noma de Madrid, Madrid, Spain include immune, genetic and other defects at the sperm e-mail: [email protected] subcellular level related to oxidative stress (OS) and 123 1038 Int Urol Nephrol (2014) 46:1037–1052 chromatin integrity [6]. Specialized andrology testing is test systems, and quality assurance during all testing pro- aimed at shedding light on these problems though factors cesses [13]. such as tests’ complexity, difficulties in interpretation, Despite being helpful, routine semen analysis is limited uncertainties about their clinical validity and lack of treat- in its ability to predict the male fertility potential unless ment options limit their routine application [7, 8]. In fact, parameters are at extreme low levels [14]. Among infertile assisted reproductive techniques (ART) are often the treat- men, semen analysis results are normal in up to 40 % of the ment many couples prefer to solve their unexplained infer- cases [12, 15, 16]. In addition, it rarely provides a diagnosis tility problem provided they are overall successful and its usefulness to recommend a treatment modality has irrespective of the underlying infertility cause [9]. As a result, been challenged by the recently released World Health the andrology clinical laboratory is not very much regarded Organization (WHO) reference standards [14, 17–19]. Of beyond its role in performing a routine semen analysis. note, the reference limits of sperm morphology (strict cri- Notwithstanding, novel information from both basic and teria; Tygerberg method) were lowered to 4 % in contrast clinical andrology research has emerged, and the factors to 14 % as in the previous standards [18, 19]. Infertility that contribute to sperm dysfunction are now better specialists have relied on strict morphology cutoff points to understood [8]. The challenge is how to translate these new recommend treatment modalities since 1988, when its evidence and technology advances to the clinical scenario. relevance to in vitro fertilization (IVF) and intrauterine In an era of increasing cost consciousness, it is paramount insemination (IUI) success rates was demonstrated by for clinicians and healthcare providers alike to be able to Kruger and colleagues [20]. Specifically, values below 4 % investigate couples with unexplained infertility in a cost- have been used to recommend intracytoplasmic sperm effective and evidence-based manner. This approach may injection (ICSI) rather than conventional IVF or IUI due to not only provide a better understanding of the underlying the markedly lower pregnancy outcomes of these two infertility cause but is also likely to lead to better, more treatment methods when using semen with low proportion cost-effective and less invasive treatments. In this review, of normal sperm [21, 22]. Interestingly, the distribution of we discuss the role and clinical significance of specialized semen analysis results of fertile men in centiles, as shown andrology tests for men with unexplained infertility taking by the new WHO standards, demonstrated that even though into consideration a translational medicine (TM) approach. 5 % of the studied men had morphology values below the We hope that the thoughts expressed here may clarify some 4 % cutoff point, they still were able to initiate an unas- misconceptions on the matter concerned and be of broader sisted pregnancy within 12 months of unprotected inter- use for doctors treating infertility patients. course, thus contradicting the current practice [17, 18]. It should be noted, however, that reference values, as pro- posed by the WHO, merely represent the distribution of Why we need to go beyond the routine semen analysis semen parameters of a limited group of recent fathers. As the WHO standards have been adopted by most andrology Semen analysis, often ordered by the gynecologist during laboratories over the years, more men will be placed into the female infertility workup, is the most widely used the category of UMI due to the lowered reference limits. biomarker to predict the male fertility potential [10]. It As noted by Esteves et al. [17], it is still unclear whether provides information on the functional status of the semi- the newly released WHO reference standards will result in niferous tubules, epididymis and accessory sex glands, and a more cost-effective evaluation of the infertile couple or in its results are often taken as a surrogate measure of a man’s a delay in the definitive diagnosis and management of the ability to father a pregnancy. Routine semen analysis infertile couple. Collectively, these findings indicate that include as follows: (a) physical characteristics of semen, physicians treating infertile couples should exercise cau- including liquefaction, viscosity, pH, color and odor; tion when interpreting the results of routine semen analysis. (b) specimen volume; (c) sperm concentration; (d) sperm Semen analysis alone is usually insufficient for diagnosis, motility and progression; (e) sperm morphology; (f) leu- as it does not account for sperm dysfunction, such as kocyte quantification; and (g) fructose detection in cases immature chromatin, OS and DNA damage. where no spermatozoa are found and ejaculate volume is low [11]. Intraindividual variation in semen parameters is common, and therefore, at least two semen specimens Specialized andrology tests: what are they? should be evaluated [12]. Since it is a complex test, semen analysis should ideally be carried out in andrology labo- The past ratories. Minimum standards for laboratories performing semen analyses include the presence of experienced tech- For many years, particularly before the advent of ICSI, nicians, internal and external quality control, validation of tests that assessed antisperm antibodies (ASA), sperm 123 Int Urol Nephrol (2014) 46:1037–1052 1039 hyperactivation and acrosome reaction (AR), sperm bind- their ability to truly assess the multiphasic nature of HA ing and penetration to the human zona pellucida (ZP) were [32]. Hence, its role in fertility prediction remains pri- used both to investigate males with unexplained infertility
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