Day-4 embryo defragmentation to improve blastocyst formation and pregnancy outcomes
Effect of Embryo Defragmentation on Day 4 (D4) on Blastocyst Development Rate and Clinical Outcomes in ART Cycles: a Prospective RCT
This study tests whether removing cytoplasmic fragments from Day-4 morula-stage embryos helps people undergoing ICSI get more blastocysts and better pregnancy chances.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 20 Years to 42 Years |
| Sex | Female |
| Sponsor | Momo Fertilife Academic / other |
| Locations | 1 site (Bisceglie, BT) |
| Trial ID | NCT07500337 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-blind randomized controlled trial comparing mechanical or laser-assisted defragmentation of Day-4 morulae versus standard culture without intervention. Eligible participants are ICSI patients aged 18–42 with at least one Day-4 morula showing ≥10% cytoplasmic fragmentation and embryos intended for extended culture in a time-lapse incubator. Primary outcomes include blastocyst formation rates with secondary clinical outcomes such as implantation and pregnancy rates. Interventions are performed in-clinic at the designated fertility center with blinded outcome assessment.
Who should consider this trial
Good fit: People aged 18–42 undergoing ICSI who have at least one Day-4 morula with ≥10% cytoplasmic fragmentation and plan extended culture in a time-lapse incubator are ideal candidates.
Not a fit: Patients with severely reduced ovarian reserve (AMH ≤ 0.5 ng/mL), BMI ≥ 32, endometriosis, PCOS, donor gamete cycles, embryos with severe Day-3 compromise, or those using PGT-M as the primary indication are excluded and likely will not benefit from this intervention.
Why it matters
Potential benefit: If successful, the procedure could increase the number of usable blastocysts and improve pregnancy rates for patients with fragmented Day-4 morulas.
How similar studies have performed: Prior work on Day-2/Day-3 defragmentation has produced mixed results, and Day-4 defragmentation remains less studied with only limited promising but inconclusive data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bisceglie, BT
- MOMO' Fertilife — Bisceglie, Bt, Italy (Recruiting)
Study contacts
- Principal investigator: Giorgio Maria baldini, Medicine — Department of Interdisciplinary Medicine, University of Bari "Aldo Moro"
- Study coordinator: Giorgio Maria Baldini, Medical Doctor
- Email: gbaldini97@gmail.com
- Phone: +39 0803962313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.