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AI could take the guesswork out of sperm selection for IVF

NCT ID NCT07163754

Diagnosis Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests an artificial intelligence algorithm called SiDTM v2.0 that helps embryologists choose the best sperm for a procedure called ICSI (a type of IVF). Currently, sperm selection is done by eye, which can vary between experts. The AI scores each sperm based on shape and movement, aiming to make the process more objective. Researchers will compare pregnancy and embryo development rates between AI-assisted and manual sperm selection in 100 couples.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SiDTM v2.0 algorithm (artificial intelligence software for sperm selection)
What this could lead to
If successful, this AI tool could make sperm selection more consistent and potentially improve IVF outcomes, especially for couples with male infertility.
What could go wrong
This is a small, early-stage validation study (100 couples) comparing AI to manual selection. It may not show a clear benefit, and results may not apply to all fertility cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

male infertility testicular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Male fertility Sperm parameters in fertile and infertile men Sperm selection Testicular

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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Other studies related to the condition(s) this trial covers.