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New test could help IVF patients pick the best embryo without invasive biopsy

NCT ID NCT07359703

Knowledge-focused Sponsor: University Hospital, Ghent Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new test called the Aurora test, which uses cells that normally surround the egg (cumulus cells) to help select the best embryo for transfer in IVF. The test is non-invasive and aims to improve pregnancy and live birth rates compared to the standard method of judging embryos by appearance alone. About 1,028 women undergoing ICSI will participate, and the study will compare embryo selection based on morphology versus morphology plus the Aurora test.

What this could mean

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

Active substance
Aurora test (non-invasive genetic analysis of cumulus cells)
What this could lead to
If successful, this test could provide a more objective way to choose the embryo with the highest chance of pregnancy, potentially improving IVF success rates without invasive procedures.
What could go wrong
This is an early-stage study comparing the test to standard methods, and it may not show a significant improvement. The test is also specific to certain stimulation protocols, so results may not apply to 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.

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 1,028 people

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

Started

Oct 2025

Expected to finish

Jun 2029

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 to 40 years

Sex

Female 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: 1. Patients undergoing ICSI treatment, with maximum 40 years of age at time of signing the ICF 2. Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for fresh SET Day 5 with hCG or dual trigger (hCG + GnRH agonist) or Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for delayed transfer of frozen/thawed SET Day 5 after a GnRH agonist trigger, hCG or dual trigger (hCG + GnRH agonist). 3. Patients undergoing a first, second, third or fourth ICSI cycle 4. Women with body mass index (BMI) higher than 17 and lower than 35 5. Women with regular cycles (between 24 and 35 days) 6. Non-and mild-smokers (\<10 cigarettes/day) 7. AMH 1,1 ng/ml (Bologna criteria), excluding poor responders according to Bologna criteria 8. Patients with fresh ejaculated semen or frozen donor semen Exclusion Criteria: 1. Patients with less than 8 follicles (≥12mm) on the day of their last echo visit before OPU. 2. Women with history of poor oocyte maturation in a previous cycle (\< 50% MII) 3. Women with Severe Endometriosis (≥ III AFS classification) (in the ovaries and if not surgically treated) 4. Patients scheduled for PGD (preimplantation genetic diagnosis of monogenic/single gene defects) and PGT-A (preimplantation genetic testing on aneuploidy) 5. Couples where the partner has an extremely low sperm count e.g.: severe oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml or TESE.

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

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

Infertility assisted reproductive technology

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

  • Ghent University Hospital

    RECRUITING

    Ghent, Belgium

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