Infertility is defined as a failure of a couple to achieve a pregnancy after 12 or more months of unprotected intercourse. Males are found to be solely responsible for 20-30% of infertility cases but contribute to 50% of cases overall. The selection of sperm to microinject is completely subjective and there is high intra- and inter- observer variability. SiDTM v2.0 is an algorithm which analyses real-time seminal samples located at ICSI dishes. Particularly, it assesses morphology and several motility parameters of each sperm, and it assigns a categorical and numerical score to each one. Categorical scores are represented by colours: green colour for optimal sperm, yellow for good sperm, orange for medium-quality sperm and red for low-quality sperm. Numerical scores ranged from 0 to 100, with higher scores for those best-quality sperm. SiDTM v2.0 can reduce subjectivity of the sperm selection process to the maximum, selecting the optimal sperm in real time. In addition, it could help junior embryologists to perform this complex and tedious procedure, which is the sperm selection for ICSI. To carry out the study, we will conduct a prospective cohort study in a total of 100 couples. Therefore, the aim of this study is to validate SiDTM v2.0 as an useful Artificial Intelligence-tool for sperm selection; that means achieving , at least, same clinical results as sperm selection performed by the embryologist.
Patients with indication for ICSI.
Women of advanced maternal age (>35 years) in whom at least 4 oocytes in metaphase II stages are obtained in the follicular puncture, without excluding patients from the oocyte donation program.
Sperm obtained by masturbation with a concentration above 1 million spermatozoa/mL after sperm capacitation.
Normal karyotype of both partners.
Patients diagnosed with recurrent gestational loss.
Semen extracted by testicular biopsy.
Semen samples with globozoospermia (sperm defect due to lack of acrosome) or azoospermia (absence of spermatozoa in the ejaculate).
Semen samples treated with pentoxifylline.
Parallel
Automated Sperm Selection
Diagnostic testThis group of oocytes will be microinjected with sperm selected by the second version of SID TM (SID V2.0) wich analyses additional sperm parameters than first version of SID TM (SID V1.0).
Conventional Sperm Selection
Diagnostic testHalf of the oocytes will be microinjected with sperm selected by the embryologist without SID assistance, based on the conventional and visual assesment of seminal samples located at ICSI dishes.
SID TM V2.0 VALIDATION
The main objective of this study is to test whether assisted sperm selection using the artificial intelligence algorithm SiDTM v2.0 equals or exceeds the mean rate of useful blastocysts obtained by conventional unassisted sperm selection by SiDTM v2.0.
Fertilization assesment (SID vs NO SID)
Fertilization rate (SID VS NO SID)
Embryo development assesment (SID vs NO SID)
Embryo development rate (SID VS NO SID)
Clinical outcomes assesment (SID vs NO SID)
Gestation rate.
Clinical outcomes assesment (SID vs NO SID)
Implantation rate
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Instituto Valenciano de Infertilidad, IVI VALENCIA
Lead sponsor
IVF 2.0 Limited
Collaborator
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