To investigate which infertile men with semen parameters above WHO reference limits at first semen analysis deserve a second semen test.
Data from 1358 consecutive infertile men were analysed. Patients underwent two consecutive semen analyses at the same laboratory. Descriptive statistics and logistic regression models tested the association between clinical variables and semen parameters. A new predicting model was identified through logistic regression analysis exploring potential predictors of semen parameters below WHO reference limits after a previously normal one. Diagnostic accuracy of the new model was compared with AUA/ASRM and EAU guidelines. Decision curve analyses (DCA) tested their clinical benefit.
Of 1358, 212 (15.6%) infertile men had semen parameters above WHO reference limits at first analysis. Of 212, 87 (41.0%) had a second semen analysis with results above WHO reference limits. Men with sperm parameters below reference limits at second analysis had higher FSH values, but lower testicular volume (TV) (all p<0.01) compared to men with a second semen analysis above WHO limits. At multivariable logistic regression analysis, lower TV (OR 0.9, p = 0.03), higher FSH (OR 1.2, p<0.01), and lower total sperm count (OR 0.9, p<0.01) were associated with second semen analyses below WHO limits. DCA showed the superior net benefit of using the new model, compared to both AUA/ASRM and EAU guidelines to identify those men with a second semen sample below WHO limits after a previously normal one.
Approximately 60% of infertile men with a first semen analysis above WHO limits have a second analysis with results below limits. The newly identified risk model might be useful to select infertile men with initial semen results above WHO limits who deserve a second semen analysis.

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In order to ensure the quality and integrity of diagnostic semen analysis results, materials used should be tested to ensure that they do not interfere with sperm function. As a toxicity test, complex sperm function testing may be considered controversial, since the fertilizing capacity of single sperm can never be assured. In preference, sperm motility offers a unique means of assessing the toxicity of reagents and materials before they are used in routine practice. Motility is the semen parameter most likely to be influenced by the external environment. Indeed, it is the main reason that laboratories insist on supplying their own approved specimen containers and ensuring that patients, as far as possible, adhere to strict conditions for sample collection and transport prior to testing. This differs to other indirect tests of toxicity such as the mouse embryo assay, whereby the rate of mouse pre-implantation embryo development to the blastocyst stage is compared. This guideline is aimed at health care scientists who deal with andrology in both general pathology and specialised fertility laboratories, and provides a model approach to sperm toxicity testing. For assisted reproduction clinics, the same methodology can be used to test any consumables that are used for sperm processing, and as an indirect guide for any consumables that come into direct contact with oocytes and pre-implantation embryos.

Uncertainty of measurement has become a paramount factor to consider in pathology. In the UK, consideration of uncertainty of measurement is mandatory for medical laboratories who apply to be accredited against ISO15189:2012 via the United Kingdom Accreditation Service. This guideline intends to help those working within diagnostic andrology to better understand the concept of uncertainty, and how it can be applied to semen analysis and post-vasectomy semen analysis. The various areas where uncertainty may exist are identified, and guidance is provided to minimise this uncertainty. This guidance is produced by the Association of Biomedical Andrologists alongside experts in the field of andrology, in order to aid laboratory scientists in understanding and undertaking important tasks that will improve quality of their service.

This article suggests that diagnostic semen analysis has no more clinical value today than it had 25-30 years ago, and both the confusion surrounding its evidence base (in terms of relationship with conception) and the low level of confidence in the clinical setting is attributable to an associated high level of \'uncertainty\'. Consideration of the concept of measurement uncertainty is mandatory for medical laboratories applying for the ISO15189 standard. It is evident that the entire semen analysis process is prone to error every step from specimen collection to the reporting of results and serves to compound uncertainty associated with diagnosis or prognosis. Perceived adherence to published guidelines for the assessment of sperm concentration, motility and morphology does not guarantee a reliable and reproducible test result. Moreover, the high level of uncertainty associated with manual sperm motility and morphology can be attributed to subjectivity and lack a traceable standard. This article describes where and why uncertainty exists and suggests that semen analysis will continue to be of limited value until it is more adequately considered and addressed. Although professional guidelines for good practice have provided the foundations for testing procedures for many years, the risk in following rather prescriptive guidance to the letter is that unless they are based on an overwhelmingly firm evidence base, the quality of semen analysis will remain poor and the progress towards the development of more innovative methods for investigating male infertility will be slow.

Because it could constitute an additional tool for Assisted Reproductive Technologies decisions, Motile Sperm Organelle Morphology Examination (MSOME) has received an increased attention, especially for its applications for diagnosis and prognosis. On the methodological side, most of teams use a similar definition of a normal spermatozoon observed with MSOME. On the contrary, the classification of the abnormal sperms is less consensual because at least six classifications were published. No satisfying standard is published. Furthermore, the nature of vacuoles observed with MSOME is widely discussed. Initially considered as nuclear, some authors rather suggested an acrosomic origin, or a mixed origin, while the others give arguments for a nuclear origin. Moreover, very few data concerning thresholds are available and the MSOME indications are still controversial. So, the MSOME is a tool of which evaluation is in progress and its clinical interests are not demonstrated at the moment.

Primary ciliary dyskinesia (PCD) is associated with abnormal ciliary structure and function, which results in retention of mucus and bacteria in the respiratory tract, leading to chronic oto-sino-pulmonary disease, situs abnormalities and abnormal sperm motility. The diagnosis of PCD requires the presence of the characteristic clinical phenotype and either specific ultrastructural ciliary defects identified by transmission electron microscopy or evidence of abnormal ciliary function. Although the management of children affected with PCD remains uncertain and evidence is limited, it remains important to follow-up these patients with an adequate and shared care system in order to prevent future lung damage. This European Respiratory Society consensus statement on the management of children with PCD formulates recommendations regarding diagnostic and therapeutic approaches in order to permit a more accurate approach in these patients. Large well-designed randomised controlled trials, with clear description of patients, are required in order to improve these recommendations on diagnostic and treatment approaches in this disease.

A 28-day repeated oral dose toxicity study of nonylphenol (NP) was performed for an international validation of the \'Enhanced OECD Test Guideline 407\' paying particular attention to the sensitivity of individual endocrine-related parameters. Sprague-Dawley rats, each group consisting of ten males and ten females, were administered NP once daily by gavage at doses of 0 (control), 10, 50, or 250 mg/kg body weight. At 250 mg/kg, three females died or became moribund during the experiment. At this dose, hepatic and renal toxicity was evident in both sexes with increase of relative liver and kidney weights as well as histopathological changes, such as centrilobular liver cell hypertrophy and a variety of renal tubular lesions, and alteration of serum biochemical parameters, some of them being evident from 50 mg/kg in females (glucose and inorganic phosphates). Hematologically, development of anemia was evident at 250 mg/kg in both sexes. Regarding endocrine-related effects, increase of thyroid weight in males was detected from 50 mg/kg. At 250 mg/kg, males exhibited reduction of relative weights of the ventral prostate and seminal vesicles, and females developed irregular estrous cyclicity and vaginal mucosal hyperplasia. Although changes in serum hormone levels were detected in both sexes, magnitude of the changes was small to be regarded as a low toxicological significance. In summary, repeated oral doses of NP to rats for 28 days resulted in hepato-renal toxicity from 50 mg/kg and anemia at 250 mg/kg. Effects on the endocrine system were observed from 50 mg/kg, and assessment of weights and histopathology of endocrine-related organs and estrous cyclicity may be valid in a battery for detecting endocrine effects of NP. The no-observed-adverse-effect level of NP was estimated to be 10 mg/kg per day.

OBJECTIVE: Postmortem sperm retrieval (PMSR) raises serious medical and ethical concerns. In this study we report the effect of intra-institutional guidelines developed for the permissibility of the procedure on the number of procurement procedures performed.
METHODS: The family members of 22 men who died suddenly sought PMSR. We performed an institutional review board approved chart review of the requests for PMSR from 1994 to 2002. A set of guidelines addressing PMSR was developed by a panel of experts at our institution. Key elements included 1) evidence of intended paternity for the deceased man, 2) next of kin/legal consent (i.e. only the wife can give consent for PMSR), 3) the death was sudden (permitting retrieval less than 24 hours post mortem) and 4) consent to a 1-year waiting period for bereavement and assessment of recipient.
RESULTS: Of the 22 families who sought PMSR 18 were not candidates for retrieval based on the criteria established by the guidelines. Four men 29 to 36 years old underwent PMSR after death and maintained on a respiratory (2) or within the first 24 hours after death (2). Procedures performed included vasal aspiration in 3 patients and epididymal/testicular retrieval in 1. Average specimen volume (including medium) was 2.1 cc, the average number of vials cryopreserved per patient was 3, sperm count was 17.6 million per ml and motility was 8.7%. All specimens demonstrated post-thaw motility. Only 1 wife used retrieved sperm for an in vitro fertilization cycle, and no pregnancy was obtained.
CONCLUSIONS: The exclusionary guidelines presented provide a framework utilized at 1 institution for consideration of requests for PMSR and dramatically decreased the number of postmortem sperm retrievals performed.

To develop and pre-validate an enhanced protocol for OECD Test Guideline 407, we performed a 28-day repeated-dose toxicity study using the administration of propylthiouracil (PTU) and tamoxifen (TAM) in Sprague-Dawley (SD) rats. Six male and female SD rats were treated orally with PTU in corn oil at the dose of 0, 0.1, 1, or 10 mg/kg per day and TAM at dose of 0, 5, 30 or 200 microg/kg per day for 4 weeks. In the study using PTU, the body weights were reduced from the third week of the study in 10 mg/kg per day group. In clinical biochemistry, the levels of 3,5,3\'-triiodothyronine (T3) and thyroxine (T4, 3,5,3\',5\'-tetraiodothyrosine) were also significantly decreased in 10 mg/kg per day group. Also, thyroid glands in 10 mg/kg per day group were bigger than those in the control group. In the histopathological examination, diffuse hyperplasia and hypertrophy of thyroid follicular cells were observed in all treatment groups, leading to the reduction of lumen size and papillary enfolding of lining epithelium. In the study using TAM, the body weights were reduced from the first week of the study in 200 microg/kg per day group. Relative testes and epididymes weights were increased and relative right ovary and uterus weights were reduced in 200 microg/kg per day group. Also, in the histopathological finding severe endometrial squamous metaplasia and endometrial gland atrophy and severe follicular cystic change were observed in TAM 200 microg/kg per day-treated group. On the basis of the results, the thyroid hormone levels, gross findings, and histopathological findings may be useful parameters for the detection of the endocrine-related effect of PTU and also reproductive organ weight and histopathological findings may be good parameters to detect the effect of TAM. Therefore, it is concluded that enhanced OECD TG407 might be useful for screening and detecting endocrine disrupters.