Day-3 vs Day-5 Assisted Hatching: Impact on Blastocyst Morphology and PGT-A Outcomes

Recruiting now · Not applicable

Conditions studied: Infertility; In Vitro Fertilization; Embryo Development

In brief

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.

Key facts

Study ID

NCT07154875

Run by

Hoang Minh Ngan

People needed

200

Starts

2025-06-14

Expected to finish

2028-06-14

Last updated by the study team

2025-09-05

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Center for Reproductive Support, 16A Ha Dong General Hospital — Hanoi, Hanoi, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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