Some male infertility biomarkers are etiologically linked to idiopathic infertility in men, the direct cause of which often cannot be determined with conventional sperm count parameters. Open questions remain regarding the universal and generic infertility definitions that cover and combine the clinical, epidemiological, and demographic perspectives. The main effort in the application of these infertility biomarkers are accounted by more or less strict discrimination criteria. For male infertility, beyond classical sperm count assessments, the DNA fragmentation index (DFI) is an adequate biomarker. DFI strongly correlates with pregnancy rates and even strict discrimination criteria for infertility outcomes. Other common biomarkers are reactive oxygen species (ROS) and antisperm antibodies (ASAs), which can explain some biomedical infertility disorders within major constraints. More frequently applied in demographic research, telomere length component analysis is based on identifying the genetic impact of cellular longevity. Sperm telomere length is becoming established as a potential biomarker in infertility research.

The aim of this review is to provide an overview of the current status and limitations to the application of novel biomarkers, including TEX101, for infertility research. The review also discusses potential options for the use of biomarkers in population-based studies.