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New embryo test could boost IVF success without poking the embryo

NCT ID NCT04000152

Diagnosis Sponsor: Igenomix 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested a new, non-invasive way to check embryos for chromosome problems before IVF. Instead of taking a cell from the embryo, doctors analyzed the fluid the embryo grew in. The goal was to see if this method could help choose the embryo most likely to lead to a healthy pregnancy. The trial involved 296 patients but was stopped early, so we don't have final answers.

What this could mean

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

Active substance
non-invasive preimplantation genetic testing for aneuploidy (niPGT-A) via spent blastocyst media analysis
What this could lead to
If successful, this could offer a cheaper, safer way to choose the healthiest embryo for IVF without harming it.
What could go wrong
The trial was terminated early, so results are limited. The test may not be accurate enough to replace current methods, and its benefit on pregnancy rates is unproven.

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

296 people

The number who actually took part.

Started

Jun 2020

Finished

Apr 2025

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

20 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: * Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved. * IVF patients intending to undergo deferred day 6/7 blastocyst SET for any medical indication. * All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7). * ICSI, IVF or ICSI/IVF performed in fresh own oocytes from couples not undergoing PGT-A. Note: Donor sperm is allowed. * Female age: 20-40 years, both included. Exclusion Criteria: * Assisted hatching and artificial collapse before collecting SBM samples. Note: Both procedures are allowed only after collecting the culture media sample. * A known abnormal karyotype if the couple provides it at consultation. If not, karyotype is not compulsory. * Couples planning to undergo PGT-M or PGT-SR cases will be excluded. * Surrogate pregnancy (in those countries where it is allowed). * ERA test and embryo transfer according to ERA result. * Time-lapse culture systems are not allowed after day 4 of culture. * Presence of pathologies or malformations that affect the uterine cavity such as polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx during the patient's participation in the study. Patients suffering these pathologies before or after their inclusion in the study can participate if the pathology is corrected before performing any study procedure. * Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.

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Conditions

The condition(s) this trial relates to.

Abortion, Spontaneous aneuploidy chromosomal disorder Chromosome Aberrations infertility disorder

As listed by the trial registrant

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

Aneuploidy Chromosome abnormality Infertility

Contacts and locations

Locations

  • Centro Procreazione Assistita DEMETRA

    Florence, Firenze, 50141, Italy

  • Crecer: Centro de Reproducción y Genética Humana

    Mar del Plata, Buenos Aires, Argentina

  • Hospital Ruber Internacional

    Madrid, Madrid, 28035, Spain

  • Hôpital Foch

    Suresnes, Suresnes, 92150, France

  • Nilo Frantz - Centro de Reprodução Humana

    Boa Vista, Porto Alegre, 91330-002, Brazil

  • Saresa - Reproducción Humana Asistida

    Salta, Salta Province, 4400, Argentina

  • Società Italiana Studi di Medicina della Riproduzione (S.I.S.M.e.R.)

    Bologna, Bologna, 40138, Italy

  • Vida - Centro de Fertilidade

    Rio de Janeiro, Rio de Janeiro, 22793-080, Brazil

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