Use of the SiDTM v2.0 Algorithm to Assist Embiyologists in Sperm Selection During ICSI Procedures
SID_3
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
September 9, 2025
September 1, 2025
2 years
July 17, 2025
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (5)
Fertilization assesment (SID vs NO SID)
1 year
Embryo development assesment (SID vs NO SID)
1 year
Clinical outcomes assesment (SID vs NO SID)
1 year
Clinical outcomes assesment (SID vs NO SID)
1 year
Clinical outcomes assesment (SID vs NO SID)
1 year
Study Arms (2)
SID
EXPERIMENTALHalf of the MII oocytes obtained will be microinjected with spermatozoa selected by SiD TM
NO-SID
ACTIVE COMPARATORHalf of the MII oocytes obtained will be microinjected with spermatozoa selected by embriologist.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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: 38651413BACKGROUNDMendizabal-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: 35989168BACKGROUNDCarrión-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
BACKGROUNDAsada 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: 38803410BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Marcos Meseguer, PhD
IVIRMA Valencia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2025
First Posted
September 9, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share