Use of the SiDTM v2.0 Algorithm to Assist Embiyologists in Sperm Selection During ICSI Procedures (SID_3)

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status: Not yet enrolling

Conditions: Male Fertility; Testicular; Sperm Parameters in Fertile and Infertile Men; Sperm Selection

Treatments: Diagnostic Test: Conventional Sperm Selection; Diagnostic Test: Automated Sperm Selection

Study type: Interventional

Funder types: Other

Identifiers

NCT07163754

2502-VLC-027-MM

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

SID

Experimental group

Description:

Half of the MII oocytes obtained will be microinjected with spermatozoa selected by SiD TM

Treatment:

Diagnostic Test: Automated Sperm Selection

NO-SID

Active Comparator group

Description:

Half of the MII oocytes obtained will be microinjected with spermatozoa selected by embriologist.

Treatment:

Diagnostic Test: Conventional Sperm Selection