Use of the SiDTM v2.0 Algorithm to Assist Embiyologists in Sperm Selection During ICSI Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated Sperm Selection, Conventional Sperm Selection.
- Who it may be relevant to
- Registry conditions: Male Fertility, Testicular, Sperm Parameters in Fertile and Infertile Men, Sperm Selection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of the SiDTM v2.0 Algorithm to Assist Embryologists in Sperm Selection During ICSI Procedures: Impact in Biological and Clinical Outcomes
Overview
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.
Interventions
- Diagnostic test Automated Sperm Selection
This 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). - Diagnostic test Conventional Sperm Selection
Half 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.
Primary outcome measures
- SID TM V2.0 VALIDATION [Time frame: 1 year]
Secondary outcome measures (5)
- Fertilization assesment (SID vs NO SID) [Time frame: 1 year]
- Embryo development assesment (SID vs NO SID) [Time frame: 1 year]
- Clinical outcomes assesment (SID vs NO SID) [Time frame: 1 year]
- Clinical outcomes assesment (SID vs NO SID) [Time frame: 1 year]
- Clinical outcomes assesment (SID vs NO SID) [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Montjean D, Godin Page MH, Pacios C, Calve A, Hamiche G, Benkhalifa M, Miron P. Automated Single-Sperm Selection Software (SiD) during ICSI: A Prospective Sibling Oocyte Evaluation. Med Sci (Basel). 2024 Mar 27;12(2):19. doi: 10.3390/medsci12020019. PMID 38651413
- Mendizabal-Ruiz G, Chavez-Badiola A, Aguilar Figueroa I, Martinez Nuno V, Flores-Saiffe Farias A, Valencia-Murilloa R, Drakeley A, Garcia-Sandoval JP, Cohen J. Computer software (SiD) assisted real-time single sperm selection associated with fertilization and blastocyst formation. Reprod Biomed Online. 2022 Oct;45(4):703-711. doi: 10.1016/j.rbmo.2022.03.036. Epub 2022 Apr 10. PMID 35989168
- Carrión-Sisternas, L., Bori, L., Conversa, L., Viloria, T., Tejera, A. AUTOMATED REAL-TIME SPERM SELECTION FOR INTRACYTOPLASMIC SPERM INJECTION (ICSI): SIBLING OOCYTE EVALUATION. Fertility and Sterility, Volume 122, Issue 4, e350
- Asada Y. Evolution of intracytoplasmic sperm injection: From initial challenges to wider applications. Reprod Med Biol. 2024 May 27;23(1):e12582. doi: 10.1002/rmb2.12582. eCollection 2024 Jan-Dec. PMID 38803410
Identifiers
NCT: NCT07163754 · 2502-VLC-027-MM