Actively Recruiting
Day-3 vs Day-5 Assisted Hatching: Impact on Blastocyst Morphology and PGT-A Outcomes
Led by Hoang Minh Ngan · Updated on 2025-09-05
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hoang Minh Ngan
Lead Sponsor
1
16A Ha Dong General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Day-3 vs Day-5 Assisted Hatching: Impact on Blastocyst Morphology and PGT-A Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- IVF cycles with preimplantation genetic testing for aneuploidy (PGT-A)
- Women aged 20 to 45 years (donor cycles: donor's age)
- Anti-Mullerian Hormone (AMH) levels between 1 and 10 ng/mL within the past 12 months
- Antral follicle count (AFC) of 5 or more follicles (2-9 mm) on both ovaries between day 2 and 5
- Receiving controlled ovarian stimulation with antagonist or progestin-primed ovarian stimulation (PPOS) protocols
- Sperm source from ejaculated samples prepared by density-gradient or swim-up methods
- No use of surgical sperm retrieval
- No use of advanced sperm selection techniques such as IMSI, PICSI, or MACS
- Stratified analysis by age groups: under 30, 30-34, 35-39, 40 or older
You will not qualify if you...
- History of 3 or more failed IVF cycles or 3 or more consecutive miscarriages
- Indication for preimplantation genetic testing for monogenic disorders or structural rearrangements (PGT-M or PGT-SR)
- Severe medical or autoimmune conditions affecting oocytes or embryos, such as uncontrolled diabetes or active lupus
- No mature (MII) oocytes available for intracytoplasmic sperm injection (ICSI)
- Embryos not eligible for biopsy due to early zona hatching, degeneration, or poor expansion
- Use of sperm from surgical retrieval or advanced sperm selection methods (IMSI, PICSI, MACS)
- Diagnosis of polycystic ovary syndrome (PCOS) by Rotterdam criteria with 2 or more of 3 features
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Center for Reproductive Support, 16A Ha Dong General Hospital
Hanoi, Hanoi, Vietnam, 100000
Actively Recruiting
Research Team
H
HOANG M NGAN, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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