Effect of Embryo Defragmentation on Day 4 on Blastocyst Development Rate and Clinical Outcomes in ART Cycles: Prospective Randomized Controlled Trial

What this Trial Is About

This research evaluates the effect of mechanical or laser-assisted embryo defragmentation performed on Day 4 of in vitro culture on blastocyst development rates and clinical outcomes in assisted reproductive technology (ART) cycles. The study focuses on women undergoing IVF/ICSI who have embryos showing at least 10% cytoplasmic fragmentation at Day 4. It is a prospective, randomized controlled trial comparing defragmentation intervention to standard culture without manipulation, addressing a less explored stage of embryo development to clarify potential benefits. Participants are randomly assigned to either receive mechanical or laser-assisted defragmentation on Day 4 at the morula/compaction stage or to continue with standard blastocyst culture without additional intervention. The defragmentation procedure involves careful removal of cytoplasmic fragments using microsurgical aspiration or laser, conducted under controlled laboratory conditions, with embryos then cultured in time-lapse incubators until Days 5 and 6. The control group undergoes the same morphological assessments without defragmentation to ensure comparable culture conditions. During the study, participants will have their embryos assessed at multiple points including Days 1, 3, 4, 5, and 6, with blastocyst quality scored using the Gardner system. Clinical outcomes such as implantation, clinical pregnancy (heartbeat at 7 weeks), ongoing pregnancy (beyond 12 weeks), and live birth rates per embryo transfer are monitored. Data collection includes detailed embryo morphology, defragmentation procedure details, and pregnancy follow-up, with a total study duration of approximately 12 months including enrollment and clinical follow-up.

Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes