Bisceglie

Researchers are evaluating whether performing embryo defragmentation on Day 4 of in vitro culture can improve blastocyst development and clinical outcomes in women undergoing assisted reproductive technology (ART) cycles. Embryo fragmentation, which involves the presence of small cytoplasmic fragments, is a common abnormality that can reduce embryo quality and implantation potential. While defragmentation at earlier stages has been studied with mixed results, this trial focuses on the less explored Day 4 stage, corresponding to morula and compaction phases, to determine if removing fragments at this time benefits embryo development. Women undergoing IVF/ICSI cycles with embryos showing 10% or more fragmentation at Day 4 will be randomly assigned to either an intervention group receiving mechanical or laser-assisted defragmentation or a control group receiving standard embryo culture without additional manipulation. The defragmentation procedure involves microsurgical aspiration of fragments using specialized equipment in controlled laboratory conditions, with all embryos cultured in a time-lapse incubator. The study includes stratified randomization based on age, number of fragmented embryos, and use of genetic testing, with approximately 240 participants planned. Participants will be monitored through morphological assessments on Days 1, 3, 4, 5, and 6, with blastocyst quality scored using the Gardner system. Clinical outcomes such as implantation rate, clinical pregnancy rate, ongoing pregnancy, and live birth rate will be tracked. Data collection includes embryo development details, pregnancy outcomes, and safety monitoring. The primary outcome is the rate of usable blastocysts at Days 5 and 6. The total study duration includes 6 months of enrollment and 6 months of follow-up, ensuring comprehensive evaluation of embryo development and pregnancy success.