Home Semen Analysis Tests As a Screening Tool for the Initial Assessment of Patients Referred to the Fertility Clinic: Assessing the Feasibility of a Randomised Trial in the UK

Infertility, defined as the inability to conceive after 12 months of regular unprotected intercourse, is estimated to affect 1 in 7 heterosexual couples, which is an estimated 80 million couples worldwide. Semen analysis, carried out as per the WHO standards in an Andrology laboratory, is the first investigation done for the male partner and reports on multiple semen parameters. Sperm concentration, motility and morphology are the primary reported parameters. Concentration and motility are reported by the laboratory within hours of assessment following sample production, whereas morphology requires extra resources and takes several weeks to produce a report.

Currently, semen analysis requires the patient to attend a hospital clinic, which could be at a significant distance from their home, to produce a sample at a given appointment time that is then analysed by the andrology laboratory without delay. In 30% of UK couples there is an abnormality with at least one semen parameter. The discriminatory ability of semen analysis to distinguish between fertile and infertile men has been questioned, including by the WHO who write the laboratory standards that should be adhered to for examination and processing of human semen.

A systematic review (currently unpublished) of the accuracy of semen analysis as a test of fertility, when undertaken in an Andrology laboratory, concluded that only certain semen parameters in isolation are predictive of reproductive outcomes in treatment-dependent (couples undergoing fertility treatment) and treatment-independent (couples conceiving spontaneously) scenarios. The only parameters predictive of treatment-independent outcomes were sperm concentration and progressive motility. The predictive value of the other semen parameters varied widely between the included studies for treatment-dependent outcomes. Morphology, the most subjectively reported parameter, was only predictive in a population undergoing intrauterine insemination (IUI). However, these studies did not adjust for confounding factors in their statistical analysis and the quality of evidence was low overall.

Despite these findings, semen analysis is an essential component of any fertility work-up and is useful in identifying azoospermia (no sperm present in the sample) and oligozoospermia (low sperm number in the sample). However, a more efficient initial test of male fertility warrants consideration given the limited efficacy of morphology. Home semen analysis tests offer the potential to provide an alternative method for assessment of the male partner and would remove the wide variation in quality control that has been observed between andrology laboratories globally.

Home semen analysis tests can be viewed as a screening tool that provide a simplified, initial assessment of male fertility compared to semen analysis done in an Andrology laboratory, which would be the follow-up diagnostic test if the home test result was abnormal. It could be assumed that the convenience of producing a sample at home in a familiar environment is preferable and no hospital appointment is required. Indeed, a study assessing satisfaction levels of men undergoing laboratory semen analysis who either produced a semen sample at home or in a hospital clinic found significantly higher satisfaction levels by five-point questionnaire in men who produced a sample at home. In addition, a review of men who had undergone a vasectomy reported that 92% would have been more likely to complete post-procedure semen analysis if this could be carried out at home, rather than attending a clinic. This review assessed factors for non-compliance in repeat semen analysis following vasectomy. The primary barriers were noted to be distance, lack of time, and forgetfulness. Home semen analysis tests have the potential to overcome each of these barriers.