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Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes

RecruitingNAAges 20 Years - 42 YearsFemaleMomo Fertilife
NCT07500337 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Embryo fragmentation is one of the main morphological parameters assessed during in vitro culture in assisted reproductive technology (ART). The presence of anucleate cytoplasmic fragments is commonly observed in human embryos and may negatively affect developmental potential and clinical outcomes. Embryo defragmentation at early stages (Day 2-3) is an established technique in some centers, but evidence remains heterogeneous. Defragmentation at Day 4 (morula/compaction stage) represents a significantly less explored area, with promising but insufficient data to guide clinical practice. Study Objective: This study aims to evaluate whether mechanical or laser-assisted embryo defragmentation performed on Day 4 (D4) of in vitro culture improves blastocyst development rates and clinical outcomes in ART cycles, compared to standard culture without intervention. Study Design: T

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📋 Eligibility rules (as published)
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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What it tests

  • Mechanical embryo defragmentation at Day 4 (morula stage)
  • Standard embryo culture without intervention
  • Standard embryo culture without intervention
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Where

1 site
MOMO' Fertilife
Bisceglie, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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