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New AI tool could revolutionize male fertility testing for IVF

NCT ID NCT07185984

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to develop and validate an artificial intelligence tool that analyzes sperm quality using microfluidic technology. Researchers will test the tool on 200 men undergoing IVF or artificial insemination. The goal is to provide a more accurate, standardized diagnosis and recommend the best treatment, potentially improving success rates compared to current methods.

What this could mean

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

Active substance
SwimCount™ Harvester microfluidic system and AI-based diagnostic tool
What this could lead to
If successful, this could lead to a more accurate, personalized way to assess male fertility and select the best IVF treatment, potentially increasing pregnancy success rates.
What could go wrong
This is an early-stage validation study with 200 participants, so the tool may not prove accurate or beneficial in real-world settings. It also relies on existing technology and may not work for all patients.

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.

Participants

About 200 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 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.

Who is studied

The study population will include patients who attend the IVIRMA Valencia clinic for a cycle of artificial insemination or a cycle of ICSI and undergo sperm selection using the Harvester microfluidic technique.

Ages

18 to 50 years

Sex

Male participants only

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: * Men between the ages of 18 and 50 who come to the clinic to undergo an ICSI cycle. * Men between the ages of 18 and 50 who come to the clinic to undergo an artificial insemination cycle. * All embryos will be placed in a time-lapse incubator. * All women over 18 years of age who have obtained a MII number greater than or equal to 2 in oocyte retrieval, without excluding couples from the oocyte donation programme. * All men and women with a previously known normal karyotype. * Informed consent (IC) provided and signed by patients. * Exclusion criteria: * All women diagnosed with recurrent pregnancy loss. * All semen samples obtained by testicular biopsy. * All donor semen samples.

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Conditions

The condition(s) this trial relates to.

infertility disorder male infertility

As listed by the trial registrant

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

Infertility (ivf patients) Male fertility Sperm selection

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • IVI Valencia

    Valencia, 46015, Spain

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