An interventional study of Automated Sperm Selection and Conventional Sperm Selection in Male Fertility, Testicular and Sperm Parameters in Fertile and Infertile Men, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Not applicable, Interventional, and Health services research
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.
Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half of the MII oocytes obtained will be microinjected with spermatozoa selected by SiD TM
Diagnostic Test: Automated Sperm Selection
Half of the MII oocytes obtained will be microinjected with spermatozoa selected by embriologist.
Diagnostic Test: Conventional 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).
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.
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.
Time frame: 1 year
Fertilization assesment (SID vs NO SID)
Fertilization rate (SID VS NO SID)
Time frame: 1 year
Embryo development assesment (SID vs NO SID)
Embryo development rate (SID VS NO SID)
Time frame: 1 year
Clinical outcomes assesment (SID vs NO SID)
Gestation rate.
Time frame: 1 year
Clinical outcomes assesment (SID vs NO SID)
Implantation rate
Time frame: 1 year
Clinical outcomes assesment (SID vs NO SID)
Live birth rate.
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Instituto Valenciano de Infertilidad, IVI VALENCIA