Day-3 vs Day-5 Assisted Hatching: Impact on Blastocyst Morphology and PGT-A Outcomes
Randomized Controlled Trial of Assisted Hatching Timing (Day-3 vs Day-5) and Its Impact on Blastocyst Morphology and Genetic Outcomes in IVF Cycles Undergoing PGT-A
Hoang Minh Ngan
200 participants
Jun 14, 2025
INTERVENTIONAL
Conditions
Summary
This randomized controlled trial evaluates the effect of assisted hatching (AH) timing on embryo development and genetic outcomes in in vitro fertilization (IVF) cycles with preimplantation genetic testing for aneuploidy (PGT-A). Eligible patients undergoing IVF with PGT-A will have embryos randomized to receive assisted hatching either on Day-3 or Day-5 of culture, prior to trophectoderm biopsy. The primary outcome is the rate of aneuploid blastocysts. Secondary outcomes include blastocyst morphology, expansion stage, and the correlation between morphology and genetic results. The study aims to determine whether earlier or later assisted hatching affects embryo viability and the accuracy of genetic testing. The trial will provide evidence to optimize laboratory protocols in IVF centers.
Eligibility
Inclusion Criteria9
- IVF cycles with PGT-A
- Oocyte age 20-45 years (donor cycles: donor's age)
- AMH 1-10 ng/mL within 12 months
- AFC ≥5 follicles (2-9 mm, both ovaries, day 2-5)
- Controlled ovarian stimulation: antagonist or PPOS protocols
- Stratified analysis by age (\<30, 30-34, 35-39, ≥40)
- Sperm source: ejaculated samples prepared by density-gradient or swim-up
- No surgical sperm retrieval
- No advanced sperm selection (IMSI, PICSI, MACS)
Exclusion Criteria7
- History of ≥3 failed IVF cycles or ≥3 consecutive miscarriages
- Indication for PGT-M or PGT-SR (monogenic disorders, translocations)
- Severe medical/autoimmune conditions affecting oocytes/embryos (e.g. uncontrolled diabetes, active lupus)
- No MII oocytes available for ICSI
- Embryos not eligible for biopsy per SOP (early zona hatching, degeneration, poor expansion)
- Sperm from surgical retrieval or advanced sperm selection (IMSI, PICSI, MACS)
- PCOS diagnosed by Rotterdam criteria (≥2/3 features)
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Interventions
Laser-assisted zona drilling performed either on Day-3 or Day-5 of culture, depending on randomization arm.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07154875