Direct-to-consumer semen analysis products: Content, accountability, and adherence to clinical guidelines.

Background: Direct-to-consumer (DTC) semen analysis (SA) products obviate barriers that deter men from clinic testing and have made strides in providing higher quality data. However, it is unclear how well these products adhere to the 2021 WHO guidelines on examination and processing of human spermatozoa as they pertain to the evaluation of male fertility.

Objective: We investigate the content and adherence to clinical guidelines associated with consumer-facing information on DTC analysis products.

Materials And Methods: Google search terms "at-home sperm test" and "mail-in sperm test" were used to identify commercially available products. Products that were offered to providers or were designed for use after vasectomy were excluded. We determined which semen parameters each product offered; if it was validated in subfertile men and against an established semen analysis method; and if it provided guidance in accordance with the WHO 2021 guidelines and related AUA/ASRM guidelines. The accountability and esthetic appearance of content for each product were assessed using the Silberg accountability and modified Abbott's criteria, respectively. Readability was assessed using the Flesch-Kincaid score. Descriptive statistics and two-tailed t-tests were used to compare characteristics, with p < 0.05 as statistically significant.

Results: We identified 20 at-home (n = 17) and mail-in (n = 3) products. 85% of tests reported sperm concentration, with 60% and 15% of tests reporting motility and morphology, respectively. Fewer than half recommended men perform more than one test (40%), and none highlighted the need for partner evaluation. Only 25% were validated among subfertile men. Most tests lacked information on their credentials and sponsors, though were esthetically pleasing. Consumer-facing information on average required a high school level education for comprehension.

Conclusions: DTC products inconsistently provide clinical recommendations in accordance with guidelines. Additionally, while product content is on average aesthetically appealing, it may lack accountability. Formal recommendations on the content and use of such products may improve their clinical integration.