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NCT Number: NCT07163754

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automated Sperm Selection

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).

Conventional Sperm Selection

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.

Primary outcomes

  1. SID TM V2.0 VALIDATION

    Time frame: 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 outcomes

  1. Fertilization assesment (SID vs NO SID)

    Time frame: 1 year

    Fertilization rate (SID VS NO SID)

  2. Embryo development assesment (SID vs NO SID)

    Time frame: 1 year

    Embryo development rate (SID VS NO SID)

  3. Clinical outcomes assesment (SID vs NO SID)

    Time frame: 1 year

    Gestation rate.

  4. Clinical outcomes assesment (SID vs NO SID)

    Time frame: 1 year

    Implantation rate

  5. Clinical outcomes assesment (SID vs NO SID)

    Time frame: 1 year

    Live birth rate.

Study contacts

Contact information is provided by the study sponsor or research team.

LAURA CARRION, Pre-Doc Trainee

CONTACT

[email protected]

Marcos Meseguer, PhD

CONTACT

[email protected]

+34 963050999 ext. 11723

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Collaborators

  • IVF 2.0 Limited

Registry information

Official study title

Use of the SiDTM v2.0 Algorithm to Assist Embryologists in Sperm Selection During ICSI Procedures: Impact in Biological and Clinical Outcomes

Acronym: SID_3

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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