ESHRE-Clinical Evaluation of A Fully Automated Semen analysis system (LensHooke X1 POR) Based On The New AIOM(Artificial Intelligence Optical Microscopic) Technology
- Autores: Ashok Agarwal, Manesh Kumar Panner Selvam, Cheng-Teng Hsu, Cleveland Clinic, American Center for Reproductive Medicine - Department of Urology, Cleveland, U.S.A. College of Medical Science and Technology, Chung Shan Medical University, Taichung, Taiwan R.O.C.
The major shortcomings of standardizing manual semen analysis (MSA) are due to subjectivity of this test and its dependence on skills of the operator.
The development of computer-assisted semen analyzers has allowed partial automation of routine semen analysis but with limited success due to its complicated operation, and lack of accuracy at a low and high sperm count range.
The objective of this study was to evaluate the performance and efficiency of the LensHookeTM X1 PRO (X1 PRO) semen analysis device using the clinical application of precision, accuracy and time.
This pilot study was approved by the Institutional Review Board and was conducted at the Andrology Center, Cleveland Clinic in August 2018.
Operation time for semen analysis including concentration, total motility, and morphology between MSA and X1 PRO (Fig. 1) by a single operator was evaluated on 20 samples.
The intra-observer correlation between MSA and X1 PRO for sperm concentration and motility was calculated on 16 samples.
The inter-device correlation among 5 different X1 PRO devices was evaluated by analyzing sperm concentration and motility on 16 samples.
The X1 PRO took 90% lesser operation time than MSA method (52.5 ± 4.8 vs. 5.2 ± 0.5 minutes, P < 0.0001) (Fig. 2)
The regression correlation coefficient of the X1 PRO with MSA was > 0.95 for sperm concentration and motile sperm concentration (MSC) (Fig. 3 and Table 1). • Intra-observer’s precision (CV%) of the X1 PRO for concentration, motility, and progressive (PR) motility was less than 10% (Table 2).
Inter-device precision (CV%) of the X1 PRO for concentration, motility, and PR motility was lower than 10% (Table 2).
- The new artificial intelligence optical microscopic technology-based device has a higher level of precision and agreement compared to the MSA method.
- The LensHookeTM X1 PRO is a simple and quick device which offers reliable and reproducible results
of semen analysis.