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IVF breakthrough? trial tests embryo 'Defrag' to boost pregnancy chances

NCT ID NCT07500337

Disease control Sponsor: Momo Fertilife 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether removing tiny cell fragments from day-4 embryos (a procedure called defragmentation) can help them develop into healthy blastocysts and lead to more pregnancies. About 320 women undergoing IVF will be randomly assigned to have their embryos defragmented or left alone. The goal is to see if this extra step improves usable blastocyst rates and live birth outcomes.

What this could mean

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

Active substance
mechanical or laser-assisted embryo defragmentation
What this could lead to
If successful, this procedure could increase the chance of getting a usable blastocyst and achieving pregnancy in IVF cycles with fragmented embryos.
What could go wrong
This is a relatively early-stage trial with no prior large-scale evidence. The procedure involves micromanipulation and laser use, which carries a small risk of embryo damage. Results may not apply to all fertility clinics.

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 320 people

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

Started

Mar 2026

Expected to finish

Dec 2026

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

20 to 42 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. Female patients undergoing ICSI cycles at the participating center 2. Age 18-42 years 3. Presence of at least one morula with cytoplasmic fragmentation ≥10% at Day 4 morphological assessment (Grade B: 10-25%, Grade C: 26-50%, Grade D: ≥50%) 4. Embryos intended for extended culture to blastocyst stage (Day 5/Day 6) 5. All embryo cultures performed in time-lapse incubator (Geri, Genea Biomedex) 6. Written informed consent obtained prior to any study-related procedure - Exclusion Criteria: 1. Severely reduced ovarian reserve (AMH ≤ 0.5 ng/mL) 2. Body mass index (BMI) ≥ 32 kg/m² 3. Diagnosis of endometriosis 4. Polycystic ovary syndrome (PCOS) 5. Maternal age ≥ 42 years 6. History of repeated implantation failure 7. Donor gamete cycles (oocyte or sperm donation) 8. Cycles with preimplantation genetic testing for monogenic disease (PGT-M) as primary indication 9. Embryos with severe morphological compromise at Day 3 10. Concurrent participation in other interventional studies that could interfere with study outcomes 11. Inability to provide written informed consent

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Conditions

The condition(s) this trial relates to.

female infertility

As listed by the trial registrant

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

Embryo development Female infertility In vitro fertilization

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

  • MOMO' Fertilife

    RECRUITING

    Bisceglie, BT, 76011, Italy

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