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AI-Powered sperm selection could boost IVF success

NCT ID NCT06990906

Disease control Sponsor: BAIBYS Fertility 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an AI-driven device called BAIBYS™ that automatically selects sperm based on movement, size, and shape for use in IVF. Half of the eggs from each couple will be fertilized using sperm chosen by the AI, and the other half using the standard manual method. The goal is to see if the AI leads to more usable embryos and higher pregnancy rates. The trial involves 260 couples where the male partner has abnormal sperm parameters.

What this could mean

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

Active substance
BAIBYS™ System (AI-based sperm selection device)
What this could lead to
If successful, this AI tool could make sperm selection faster and more consistent, potentially leading to higher-quality embryos and more successful pregnancies in IVF.
What could go wrong
This is an early-stage study with 260 participants, so results may not apply to everyone. The device could malfunction or not improve outcomes as hoped, and there is a small risk of serious adverse events.

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 260 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

21 to 42 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Couples intended to be ICSI recruited from the clinic's IVF units. Couples may be utilizing their own gametes, or gametes from one known donor (for donated gametes, the donor will also need to consent). 2. Male subject aged ≥ 21 years at the time of screening 3. Male subjects with at least 1 abnormal parameter at the sperm analysis according to the WHO criteria (count, motility, or morphology) 4. Female subjects aged 21 to 42 years at the time of screening 5. Number of follicles ≥14 mm as measured by ultrasound evaluation at ovulation trigger is at least 11 6. The subject can provide a sperm sample by ejaculation. Sperm can be produced by electric ejaculation. Fresh or thawed sperm can be used for the procedure. 7. Total Motile sperm Count (TMC) \> 1 million 8. The subject can understand and sign a written informed consent form Exclusion Criteria: 1. Severe grade IV endometriosis (suspected or confirmed by surgery), moderate to severe adenomyosis, or a condition that is known to render implantation unlikely, such as 3 or more prior losses related to uterine issues. 2. Sperm produced by TESE (testicular sperm extraction)/TESA (testicular sperm aspiration). 3. The subjects are under active oncology treatment. 4. Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up, or testing of this study. 5. Planned sex selection or any other scenario where a less-optimal embryo is planned to be transferred 6. Anonymous donor or other donor scenarios where it is uncertain whether freely given consent can be obtained

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Conditions

The condition(s) this trial relates to.

azoospermia male infertility

As listed by the trial registrant

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

Male infertility, azoospermia

How to take part

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

  1. The places running it

    3 sites in 3 countries. 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

  • Assuta Medical Center

    Tel Aviv, 6971028, Israel

  • Care Fertility Group

    Manchester, United Kingdom

  • New England Fertility Institute

    Stamford, Connecticut, 06905, United States