Male-factor infertility accounts for nearly half of all infertility cases worldwide, yet conventional semen analysis methods—both manual and computer-assisted—can yield inconsistent results. Such inaccuracy can lead to misleading diagnosis, unnecessary interventions (e.g., IVF/ICSI), and potentially increased healthcare costs. Here, we present a novel imaging system, LuceDX, which uses a 13-fold expanded field of view (FOV) to overcome the statistical and technical limitations of standard Computer Assisted Semen Analysis (CASA) tools. By capturing a substantially larger sample area, LuceDX mitigates the non-uniform sperm distribution and clustering effects that compromise accuracy in smaller FOV methods. Pilot data indicate that this expanded-FOV platform improves measurement precision by a factor of 3.6 relative to conventional techniques, aligning with WHO guidelines while reducing the need for multiple fields per sample. This improvement is particularly advantageous in oligospermic men and post-vasectomy assessments, where accurate detection of very low sperm counts is critical in clinical decision making, especially considering real-world settings where guidelines may not be consistently applied. Our discussion highlights the patient and physician benefits of increasing accuracy and reliability toward an even better fertility treatment efficacy and underscores the importance of larger, multi-center trials to validate these findings. Taken together, the evidence suggests that LuceDX’s integrated, AI-enabled advanced image analysis offers a promising step forward in male infertility diagnostics, improving reliability, reducing costs, and potentially accelerating the optimal management of infertile couples.
Competing Interest StatementJBG, AK, AL, MEM, and RZ are employees of illumicell AI. MB, JS, and LC are employees and shareholders of illumicell AI. The authors declare no other competing interests.
Funding StatementThis study was funded by illumicell AI SARL. No external funding was received.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethics committee/IRB of Commission cantonale (VD) de ethique de la recherche sur le etre humain (CER-VD), Lausanne, Switzerland gave ethical approval for this work (Project-ID: 2023-02302).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityThe data used in the analyses of the present study are available from the corresponding author upon reasonable request.
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