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AzTrials

Male FertilitySID_3NCT07163754

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

A study testing Automated Sperm Selection and Conventional Sperm Selection in people with Male Fertility and Testicular, run by Instituto Valenciano de Infertilidad, IVI VALENCIA.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Automated Sperm Selection and Conventional Sperm Selection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Oct 2025to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Marcos Meseguer, PhD contact

+34 963050999 ext. 11723

marcos.meseguer@ivirma.com

LAURA CARRION, Pre-Doc Trainee contact

laura.carrion@ivirma.com

About this study

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

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.

Being tested
Automated Sperm Selection, Conventional Sperm Selection
Keywords
Intracytoplasmatic Sperm injection, automated sperm selection, artificial intelligence, fertilization, embryo quality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated Sperm SelectionDiagnostic 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 SelectionDiagnostic 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.

Study groups in NCT07163754
Study groupRoleWhat they receive
SIDExperimentalHalf of the MII oocytes obtained will be microinjected with spermatozoa selected by SiD TM
Receives: Diagnostic Test: Automated Sperm Selection
NO-SIDActive comparatorHalf of the MII oocytes obtained will be microinjected with spermatozoa selected by embriologist.
Receives: Diagnostic Test: Conventional Sperm Selection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (5)

  1. Fertilization assesment (SID vs NO SID)

    Fertilization rate (SID VS NO SID)

    Measured: 1 year

  2. Embryo development assesment (SID vs NO SID)

    Embryo development rate (SID VS NO SID)

    Measured: 1 year

  3. Clinical outcomes assesment (SID vs NO SID)

    Gestation rate.

    Measured: 1 year

  4. Clinical outcomes assesment (SID vs NO SID)

    Implantation rate

    Measured: 1 year

  5. Clinical outcomes assesment (SID vs NO SID)

    Live birth rate.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
The present project will be a single-center, open-label, prospective, cohort study.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163754
Sponsor's protocol ID
2502-VLC-027-MM
Acronym
SID_3
Status last verified
Sep 2025
First submitted
17 Jul 2025
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Montjean D, Godin Page MH, Pacios C, Calve A, Hamiche G, Benkhalifa M, Miron P. Automated Single-Sperm Selection Software (SiD) during ICSI: A Prospective Sibling Oocyte Evaluation. Med Sci (Basel). 2024 Mar 27;12(2):19. doi: 10.3390/medsci12020019.

    PubMed 38651413

  • Mendizabal-Ruiz G, Chavez-Badiola A, Aguilar Figueroa I, Martinez Nuno V, Flores-Saiffe Farias A, Valencia-Murilloa R, Drakeley A, Garcia-Sandoval JP, Cohen J. Computer software (SiD) assisted real-time single sperm selection associated with fertilization and blastocyst formation. Reprod Biomed Online. 2022 Oct;45(4):703-711. doi: 10.1016/j.rbmo.2022.03.036. Epub 2022 Apr 10.

    PubMed 35989168

  • Carrión-Sisternas, L., Bori, L., Conversa, L., Viloria, T., Tejera, A. AUTOMATED REAL-TIME SPERM SELECTION FOR INTRACYTOPLASMIC SPERM INJECTION (ICSI): SIBLING OOCYTE EVALUATION. Fertility and Sterility, Volume 122, Issue 4, e350

  • Asada Y. Evolution of intracytoplasmic sperm injection: From initial challenges to wider applications. Reprod Med Biol. 2024 May 27;23(1):e12582. doi: 10.1002/rmb2.12582. eCollection 2024 Jan-Dec.

    PubMed 38803410

Questions about this trial

What is this clinical trial studying?

A study testing Automated Sperm Selection and Conventional Sperm Selection in people with Male Fertility and Testicular, run by Instituto Valenciano de Infertilidad, IVI VALENCIA.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marcos Meseguer, PhD (+34 963050999 ext. 11723, marcos.meseguer@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SID TM V2.0 VALIDATION (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07163754, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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