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| Name | Class |
|---|---|
| IVF 2.0 Limited | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SID | Experimental | Half of the MII oocytes obtained will be microinjected with spermatozoa selected by SiD TM |
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| NO-SID | Active Comparator | Half of the MII oocytes obtained will be microinjected with spermatozoa selected by embriologist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Sperm Selection | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization assesment (SID vs NO SID) | Fertilization rate (SID VS NO SID) | 1 year |
| Embryo development assesment (SID vs NO SID) | Embryo development rate (SID VS NO SID) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcos Meseguer, PhD | Contact | +34 963050999 | 11723 | marcos.meseguer@ivirma.com |
| LAURA CARRION, Pre-Doc Trainee | Contact | laura.carrion@ivirma.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcos Meseguer, PhD | IVIRMA Valencia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38651413 | Background | 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. | |
| 35989168 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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The present project will be a single-center, open-label, prospective, cohort study.
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| Conventional Sperm Selection | Diagnostic Test | 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. |
|
| 1 year |
| Clinical outcomes assesment (SID vs NO SID) | Gestation rate. | 1 year |
| Clinical outcomes assesment (SID vs NO SID) | Implantation rate | 1 year |
| Clinical outcomes assesment (SID vs NO SID) | Live birth rate. | 1 year |
| Background | 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 |
| 38803410 | Background | 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. |