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

NCT07163754 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

  • Male Fertility
  • Testicular
  • Sperm Parameters in Fertile and Infertile Men
  • Sperm Selection

Interventions

DIAGNOSTIC_TEST

Automated 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_TEST

Conventional 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 & Collaborators

  • IVF 2.0 Limited

    collaborator OTHER

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

    lead OTHER

Principal Investigators

  • Marcos Meseguer, PhD · IVIRMA Valencia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07163754 on ClinicalTrials.gov