Male Fertility, Sperm Parameters in Fertile and Infertile Men, Sperm Selection, Testicular
Conditions
Keywords
Intracytoplasmatic Sperm injection, automated sperm selection, artificial intelligence, fertilization, embryo quality
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.
Interventions
DIAGNOSTIC_TESTAutomated 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_TESTConventional 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.
Sponsors
IVF 2.0 Limited
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The present project will be a single-center, open-label, prospective, cohort study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SID TM V2.0 VALIDATION | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fertilization assesment (SID vs NO SID) | 1 year | Fertilization rate (SID VS NO SID) |
| Embryo development assesment (SID vs NO SID) | 1 year | Embryo development rate (SID VS NO SID) |
| Clinical outcomes assesment (SID vs NO SID) | 1 year | Gestation rate. |
Contacts
Primary ContactMarcos Meseguer, PhD
Backup ContactLAURA CARRION, Pre-Doc Trainee
Outcome results
None listed