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Background: The power of inhibin B to predict competent spermatogenesis is not fully understood. The aims of this study were to identify the reliable reference range of inhibin B among normozoospermic men in China and to evaluate the diagnostic accuracy of serum inhibin B level as a complementary predictor of successful sperm retrieval in patients with azoospermia., Methods: This was a cross-sectional study. The male partners of 30 613 infertile couples who visited our hospital were investigated between March 2017 and March 2019. We analysed semen parameters, serum levels of reproductive hormones (inhibin B, FSH and testosterone) and sperm retrieval results from PESA/TESE in Chinese men., Results: The normal reference range of inhibin B was 87.42-299.93 pg/mL among men with normozoospermia in China. Inhibin B levels were negatively correlated with age (r = -.111; P < .001) but positively correlated with total sperm counts in the overall population, reference group and case group (r = .311, r = .208 and r = .444, respectively; P < .001). Stepwise multiple regression analyses revealed that compared with the FSH and testosterone levels, the inhibin B level had the closest relationship with the total sperm count. The best cutoff value of inhibin B for predicting the retrieval outcome of testicular/epididymal sperm was >77.72 pg/mL (sensitivity = 59.14%, specificity = 92.00% and AUC = 0.801). The inhibin B:FSH ratio (cutoff value > 6.98, sensitivity = 56.99%, specificity = 96.00% and AUC = 0.814) performed better than either the inhibin B level or the FSH level alone., Conclusion: A new reference range for serum inhibin B was established in China. However, neither serum inhibin B, FSH nor their ratio is adequate for men to decide whether to undergo PESA/TESE to determine the adequacy of spermatogenesis., (© 2019 John Wiley & Sons Ltd.)

Objective: Saline infusion test (SIT), captopril challenge test (CCT), fludrocortisone suppression test (FST) and oral sodium loading test (SLT) are recommended by the Endocrine Society's Clinical Practice Guidelines to diagnose primary aldosteronism, but which one is the best remains controversial. We aimed to summarize the available comparative data and evaluate the diagnostic accuracy of these four tests., Design: We searched PubMed, Embase and the Cochrane Library for relevant studies published between January 1980 and January 2018., Patients: Eligible studies reported on the accuracy of one or more of the four confirmatory tests in patients suspected of PA., Measurements: Two reviewers independently conducted the data extraction of all selected studies, which consisted of study characteristics and data to estimate the summary receiver operating characteristic (SROC) curve and the corresponding summary area under the curve (SAUC), pooled sensitivity and specificity, diagnostic odds ratios (DOR) with 95% confidence interval (CI)., Results: We identified 26 articles including 3686 patients. Fifteen articles evaluated the diagnostic accuracy of CCT, 10 of SIT, 1 of FST and none of SLT. For CCT, the SAUC was 0.9207, and the pooled sensitivity and specificity were 0.87 (95% CI: 0.84-0.89) and 0.84 (95% CI: 0.81-0.86), respectively. For SIT, the SAUC was 0.9232, and the pooled sensitivity and specificity were 0.85 (95% CI: 0.82-0.87) and 0.87 (95% CI: 0.85-0.89), respectively. For FST, the pooled sensitivity and specificity were 0.87 (95% CI: 0.66-0.97) and 0.95 (95% CI: 0.82-0.99), respectively. Overall, we found no significant differences in the diagnostic accuracy of CCT and SIT., Conclusions: CCT and SIT exhibit high and comparable accuracy for diagnosing PA. CCT may be a more feasible alternative as it is safe and much easier to perform., (© 2019 John Wiley & Sons Ltd.)

Objective: Although corticotropin is a representative secretagogue of aldosterone, the utility of the cosyntropin stimulation test (C-ST) in diagnosing primary aldosteronism (PA) has not been elucidated. Aim of the study was to evaluate the clinical utility of C-ST for confirmatory testing and subtype classification of PA., Design, Setting and Patients: In this retrospective study, we identified patients with hypertension and positive case-detection results for PA who underwent C-ST and saline infusion testing (SIT) between 2006 and 2013 at eight referral centres in Japan. PA and essential hypertension (EH) were distinguished based on SIT results. PA subtype classification was determined by adrenal venous sampling (AVS). Plasma aldosterone concentration (PAC) was measured before and 30 and 60 min after intravenous cosyntropin administration. The ability of C-ST to distinguish PA from EH and to distinguish unilateral from bilateral disease was assessed by the area under the receiver operating characteristic curve., Results: Of 205 patients with hypertension and positive case-detection results, 139 (68%) had PA based on SIT results. Eighteen patients in whom AVS was unsuccessful were excluded from analysis. The baseline PAC before C-ST was significantly higher (P < 0·01) in patients with PA than in those with EH. However, the degree of difference in PAC between patients with PA and EH was not enhanced by the administration of cosyntropin. In addition, the administration of cosyntropin did not improve the distinction between bilateral and unilateral PA subtypes., Conclusions: C-ST has no utility as a confirmatory and subtype testing of PA when the diagnosis of PA is based on the positive results in SIT., (© 2016 John Wiley & Sons Ltd.)

Context: The short ACTH stimulation test (250 μg) is the dynamic test most frequently used to assess adrenal function. It is possible that a single basal cortisol could be used to predict the dynamic response, but research has been hampered by the use of different assays and thresholds., Objective: To propose a morning baseline cortisol criterion of three of the most commonly used modern cortisol immunoassays - Advia Centaur (Siemens), Architect (Abbott) and the Roche Modular System (Roche) - that could predict adrenal sufficiency., Design: Observational, retrospective cross-sectional study at two centres., Patients and Measurements: Retrospective analysis of the results of 1019 Short Synacthen tests (SSTs) with the Advia Centaur, 449 SSTs with the Architect and 2050 SSTs with the Roche Modular System assay. Serum cortisol levels were measured prior to injection of 250 μg Synacthen and after 30 min. Overall, we were able to collate data from a total of 3518 SSTs in 3571 patients., Results: Using receiver-operator curve analysis, baseline cortisol levels for predicting passing the SST with 100% specificity were 358 nmol/l for Siemens, 336 nmol/l for Abbott and 506 nmol/l for Roche. Utilizing these criteria, 589, 158 and 578 SSTs, respectively, for Siemens, Abbott and Roche immunoassays could have been avoided., Conclusions: We have defined assay-specific morning cortisol levels that are able to predict the integrity of the hypothalamo-pituitary-adrenal axis. We propose that this represents a valid tool for the initial assessment of adrenal function and has the potential to obviate the need for dynamic testing in a significant number of patients., (© 2016 John Wiley & Sons Ltd.)

Objective: To evaluate the use and interpretation of growth hormone (GH) stimulation tests used across the UK for diagnosing GH deficiency., Background: Previous studies show poor consensus on the use of GH stimulation tests. Sex steroid priming and retesting in the transition period are areas not previously surveyed., Design: Data were collected from tertiary paediatric endocrinologists, paediatricians with a specialist interest in endocrinology and biochemists across the UK over 6 months through distributing electronic surveys., Results: At least three different GH stimulation tests were used by 33% of departments. Glucagon and insulin doses varied most, and sampling frequency varied most using insulin. All laboratories use a recommended chemiluminescence immunoassay with an acceptable coefficient of variability. The GH peak for diagnosing GH deficiency varied from 6 to 8 μg/l. A wide range of clinical scenarios prompted retesting in the transition period, suggesting nonstandardized current practice. Seventy-five per cent of departments use sex steroid priming, but follow criteria variously combining bone age, chronological age and pubertal stage, together with variations in steroid type and dose., Conclusions: Although a contentious diagnostic test, GH stimulation tests remain the gold standard for diagnosing GH deficiency. Our data suggest that together with variation in indication, protocol and interpretation, there is considerable variation in current practices pertaining to priming and retesting in transition. Given the current financial climate and the need for careful resource management, this study emphasizes the considerable need for consensus in the investigation, diagnosis and long-term follow-up of these children, at least nationally if not internationally., (© 2016 John Wiley & Sons Ltd.)

Objective: Acromegaly, a disease caused by GH/IGF-I hypersecretion, is associated with a high mortality rate; early recognition is therefore necessary to ensure successful treatment and to avoid comorbidities. We have created a symptom/sign scoring tool (ACROSCORE) for physicians to use to identify acromegaly., Design: To compare cases of acromegaly diagnosed between 1990 and 2014 against a control group affected by non-GH-secreting pituitary tumours to identify symptoms and signs that are most discriminative for acromegaly., Patients: Confirmed acromegaly patients and patients affected by non-GH-secreting pituitary tumours., Measurements: In all patients, signs, symptoms and comorbidities were recorded from medical records and collected using a specifically designed questionnaire., Results: A total of 194 acromegaly patients [115 women; mean (SD) age 47·2 (14·2) years] and 243 patients affected by non-GH-secreting pituitary tumours [131 women; mean (SD) age 45·8 (15·8) years] were included. A strong association was observed for type 2/secondary diabetes [odds ratio (OR) 3·7], hyperhidrosis (OR 6·1), thyroid hyperplasia (OR 13·9), colorectal polyps (OR 10·4), spaced teeth (OR 25·4) and carpal tunnel syndrome (OR 4·3). Based on this information, a multivariable logistic model was built and a 14-point scoring system developed. A score of 0 excludes the risk of acromegaly [positive predictive value (PV(+)) = 0·6%]; scores 1-5 comprise a grey area; scores >5 indicate that a diagnosis of acromegaly cannot be excluded (PV(+) = 46·1%)., Conclusions: Once validated in independent studies, ACROSCORE may represent a new tool for the clinical screening of acromegaly that can be used by general practitioners and nonendocrinology specialists., (© 2015 John Wiley & Sons Ltd.)

Objective: To analyse the effectiveness of age on HbA1c as a criterion for the diagnosis of diabetes in Chinese different age subjects., Methods: This retrospective study enrolled a total of 1147 outpatients with untreated newly diagnosed diabetes (aged 18-80 years, 42·55% women) from the Fujian Province, China, and 427 age and gender-matched (control) subjects without diabetes. Receiver operating characteristic curve (ROC) was plotted to determine the performance of HbA1c against results of oral glucose tolerance test (OGTT) performed at the same time according to specific age groups. The ORs and 95%CIs between diabetes and other metabolic disorders were analysed., Results: (i) HbA1c provided an age-specific diagnosis for diabetes: there was a high diagnostic titter of HbA1c in the 18- to 39-year age group; conversely, there was a low diagnostic titter of HbA1c in the ≥70-year-old age groups. (ii) After adjusted for age, individuals with diabetes by OGTT criteria but not by WHO HbA1c criteria had an increased chance of having abnormal weight, hypertriglyceridaemia, HDL hypocholesterolaemia and insulin resistance. (iii) The diagnostic cut-off points of HbA1c for diabetes in different age groups (18-39, 40-49, 50-59, 60-69 and ≥70 years) were 6·1, 6·3, 6·4, 6·5 and 6·4, respectively. The age-specific HbA1c criteria exhibited the higher positive rate, sensitivity and lower false-negative rate when compared with WHO HbA1c criteria., Conclusions: This provided evidence indicating that there may be drawbacks in the use of HbA1c in the diagnosis of diabetes. Thus, we proposed that the impact of introducing HbA1c for diabetes diagnosis should be considered in terms of age. Cohort studies are needed to further confirm the suitability of age-specific HbA1c criteria for the diagnosis of diabetes., (© 2014 John Wiley & Sons Ltd.)

Background: In boys undergoing investigation of gonadal function, the relationship between a single measurement of serum anti-Mullerian hormone (AMH) and hCG stimulated serum testosterone is unclear., Aim: The aim of the study was to assess concordance between serum AMH and testosterone concentrations following hCG stimulation of two different durations., Methods: Samples from 284 children (M : F, 154 : 130) with a median age of 8 years (10th, 90th centiles, 0.25, 14) were used to establish an AMH reference range. Clinical data were reviewed in boys undergoing investigation of gonadal function and who had an AMH measurement and a hCG stimulated (3-day or 3-week) (n = 26) testosterone. Of these 26 boys, 11 had combined genital anomalies, whereas the rest had conditions such as isolated hypospadias, undescended testes or microphallus. Normal testosterone response to hCG stimulation was defined as a level greater than 3.5 nmol at day 4 and 9.5 nmol/l at day 22., Results: In the reference group, the 5th centile AMH for boys below 1 year was 215 pmol/l and between 1 and 8 years 180 pmol/l. The 95th centile for girls for these respective age groups was 30 pmol/l and 25 pmol/l. In those cases where serum testosterone concentrations were available at day 1, day 4 and day 22 of the 3 week-hCG test, five cases had a normal serum testosterone at day 4 and three cases only showed such a response by day 22. In those where serum AMH was less than 180 pmol/l, a poor testosterone response of less than 3.5 nmol was observed in approximately seven of eight (88%) cases with a 3-day hCG stimulation test or the 3-week test. An AMH of greater than 180 pmol/l was associated with a normal testosterone response at day 4 in 10 out of 15 (67%) cases and at day 22 in eight of 11 (73%) cases. However, a low serum testosterone concentration of less than 3.5 nmol after the 3-day hCG test was only associated with a likelihood of a low AMH in three of eight (37%) cases. With the 3-week hCG test, a low day 22 testosterone of 9.5 mmol/l or less was associated with a low AMH of 180 pmol/l or less in four of seven (57%) cases., Conclusion: In boys undergoing investigation of gonadal function, the concordance between AMH and testosterone is better at day 22 than day 4. A normal AMH may provide useful information on overall testicular function but does not exclude the need for an hCG stimulation test.

Objective: To assess if a cell-based readout of androgen action in serum demonstrates a closer association with recognized classical parameters of androgen action in men than current measures of serum testosterone (T)., Design: To develop, validate and utilize a mammalian cell-based assay to measure specifically bioactive T and determine if this measure is a physiologically relevant fraction of serum T. MEASUREMENTS AND PARTICIPANTS: We have developed a specific serum T bioassay using human prostate cancer cells. A rapid 5-min exposure to 100% serum followed by serum withdrawal confers specificity of the assay to serum T and provides sufficient sensitivity to measure T in male serum samples. Matrix effects were experimentally discounted as a confounding issue. A total of 960 male serum samples from the Florey Adelaide Male Ageing Study (FAMAS) with previous comprehensive cohort data and serum measurements were utilized., Results: Bioassay T measurement in the 960 FAMAS serum samples returned a median of 10.7 nmol/l (1.7-45.4), and was most closely related to immunoassayed total T, but not immunoassayed bioavailable T or calculated free T. Immunoassayed total T demonstrated a positive association with isometric grip-strength (R(2) = 0.127, P < 0.001), self-reported sexual desire (R(2) = 0.113, P < 0.001) and erectile function (R(2) = 0.085, P < 0.05) while bioassay T did not., Conclusions: While cellular bioassays offer a rapid and sensitive means of identifying the androgenic potential of complex environmental compounds, the utility of such assays in defining a clinically relevant fraction of serum T distinct from total T needs further investigation.