Use of the SiDTM v2.0 Algorithm to Assist Embryologists in Sperm Selection During ICSI Procedures: Impact in Biological and Clinical Outcomes
| Registry | NCT07163754, acronym SID_3 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, health services research |
| Enrollment | 100 (Estimated) |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA (Other); collaborators: IVF 2.0 Limited |
| Conditions | Male Fertility, Testicular, Sperm Parameters in Fertile and Infertile Men, Sperm Selection |
| Interventions | Automated Sperm Selection, Conventional Sperm Selection (Diagnostic test) |
| Dates | start 2025-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2025-09-09, last updated 2025-09-09 |
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All trials for Male Fertility All trials for Testicular All trials of Automated Sperm Selection All trials of Conventional Sperm Selection
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SID | Experimental | Diagnostic Test: Automated Sperm Selection | Half of the MII oocytes obtained will be microinjected with spermatozoa selected by SiD TM |
| NO-SID | Active comparator | Diagnostic Test: Conventional Sperm Selection | Half of the MII oocytes obtained will be microinjected with spermatozoa selected by embriologist. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. * Informed Consent (IC). Exclusion Criteria: * 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. * ICSI cycles with application of calcium ionophore. o ICSI cycles with application of calcium ionophore.