Day-4 embryo defragmentation to improve blastocyst formation and pregnancy outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.