Validation of the American Society for Reproductive Medicine guidelines/recommendations in white European men presenting for couple's infertility

Objective To retrospectively validate the American Society for Reproductive Medicine (ASRM) guidelines/recommendations concerning endocrine evaluation in a cohort of white European men presenting for couple's infertility. Design Retrospective study. Setting Academic reproductive medicine outpatient clinic. Patient(s) Cohort of 1,056 consecutive infertile men (noninterracial infertile couples). Intervention(s) Testicular volume was assessed with a Prader orchidometer. Serum hormones were measured (8–10 A.M.) in all cases. Hypogonadism was defined as total T < 3 ng/mL, according to the Endocrine Society definition. Semen analysis values were assessed based on the 2010 World Health Organisation reference criteria. Main Outcome Measure(s) ASRM indications for endocrine assessment in infertile men (sperm concentration <10 million/mL, impaired sexual function, and other clinical findings suggesting a specific endocrinopathy) were used to predict hypogonadism in our cohort. Moreover, a clinically user-friendly three-item nomogram was developed to predict hypogonadism and was compared to the ASRM guidelines assessment. Result(s) Biochemical hypogonadism was diagnosed in 156 (14.8%) men. Overall, 669 (63.4%) patients would have necessitated total T assessment according to the ASRM criteria; of these, only 119 (17.8%) were actually hypogonadal according to the Endocrine Society classification criteria. Conversely, 37 (23.7%) out of 156 patients with biochemical hypogonadism would have been overlooked. The overall predictive accuracy, sensitivity, and specificity of the ASRM guidelines was 58%, 76%, and 39%, respectively. Our nomogram was not reliable enough to predict hypogonadism, despite demonstrating a significantly higher predictive accuracy (68%) than the ASRM guidelines. Conclusion(s) The current findings show that the ASRM guidelines/recommendations for male infertility workup may not be suitable for application in white European infertile men.