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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-10-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present project will be a single-center, open-label, prospective, cohort study.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SID

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

Group Type EXPERIMENTAL

Automated Sperm Selection

Intervention Type 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).

NO-SID

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

Group Type ACTIVE_COMPARATOR

Conventional Sperm Selection

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No