Effect of fragment removal on blastocyst formation and quality of human embryos.
Poopak Eftekhari-Yazdi, Mojtaba Rezazadeh Valojerdi, Saeed Kazemi Ashtiani...
https://pubmed.ncbi.nlm.nih.gov/17169204/Actively Recruiting
Led by Momo Fertilife · Updated on 2026-03-30
320
Participants Needed
1
Research Sites
40 weeks
Total Duration
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 IVFICSI 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 morulacompaction 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.
CONDITIONS
Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes
G
Giorgio Maria Baldini, Medical Doctor
D
Domenico Baldini, Medicine
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Momo Fertilife
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial eligibility and consent
Duration - Approximately 6 days from fertilization
Participants undergo embryo culture with or without a Day 4 defragmentation procedure. Embryos are assessed and cultured until Day 5 and Day 6 to evaluate blastocyst development.
1 visit on Day 4 for embryo assessment and possible defragmentation; additional embryo assessments on Day 5 and Day 6
Duration - Up to approximately 9 months post-embryo transfer
Participants who undergo embryo transfer are monitored for clinical pregnancy outcomes including implantation, ongoing pregnancy, and live birth.
Visits at around 4 weeks, 7 weeks, 12 weeks post-transfer and follow-up until delivery
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Lead Sponsor