Abstract
Abstract Study question Can LensHooke X1 PRO semen analyzer be used to evaluate sperm morphology in men with infertility? Summary answer Morphology results generated by X1 PRO are highly reliable when normal sperm forms are ≥4% and therefore they can be reported in such cases . What is known already Most laboratories rely on manual evaluation of sperm morphology smears, which is a time-consuming procedure and its results are subjected to a relatively high variability. However, in recent years the computer-assisted semen analyzers are being increasingly used to evaluate sperm morphology. The X1 PRO semen quality analyzer was designed for in vitro diagnostic use to analyze sperm concentration, total, progressive and non-progressive motility as well as sperm morphology based on WHO 5th edition criteria. Evaluation of sperm morphology using X1 PRO based on AIOM (Artificial Intelligence Optical Microscopic)-based technology requires no fixation steps or staining unlike the manual method. Study design, size, duration This cross-sectional study used 31 semen samples from 8 normozoospermic healthy volunteers and 5 infertile men with a minimum abstinence period between 2 - 3 days. While the 8 healthy semen donors produced a total of 26 ejaculates, which were split into 88 aliquots, the 5 infertile patients produced 5 ejaculates that were split into 13 aliquots. Participants/materials, setting, methods A total of 101 aliquots were prepared from the native semen samples either by dilution or concentration using seminal plasma of the respective donors. Automated semen analysis was performed by the X1 PRO semen analyzer and the results of sperm morphology were compared with manual morphology results using Diff-Quik staining. Statistical analysis was carried out to calculate the positive predictive value (PPV) and negative predictive value (NPV) of X1 PRO semen analyzer. Main results and the role of chance The X1 PRO sperm morphology results show a weak non-significant (P = 0.2441) correlation (r = 0.119) with the manual results. However, X1 PRO demonstrated a high PPV (97.7%) and a low NPV (9.1%) for correct assessment of sperm morphology (≥4%) when compared to manual results. Due to its high PPV, laboratories can report the morphology results generated by X1 PRO in all such cases when normal sperm forms are ≥4%. However, a manual evaluation is necessary in patients with abnormal morphology (<4%). Limitations, reasons for caution One of the limitation of this study is that X1 PRO morphology values did not correlate with manual results. The low NPV seen in our study is due to the inclusion of very few samples with abnormal sperm forms (<4%) in the analysis. Wider implications of the findings: The X1 PRO’s combination of speed, ease of use, accuracy and portability makes it a good choice of device for small medical offices to large IVF centers. High PPV of X1 PRO allows it to correctly identify normal sperm forms for diagnostic use. Trial registration number 18–771
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