Day-3 vs Day-5 Assisted Hatching: Impact on Blastocyst Morphology and PGT-A Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assisted Hatching.
- Who it may be relevant to
- Registry conditions: Infertility; In Vitro Fertilization; Embryo Development. Basic parameters: 20 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
This prospective randomized controlled trial compares two standardized laboratory procedures of assisted hatching (AH) timing in IVF cycles undergoing PGT-A. In Arm A, AH will be performed on Day-3 embryos; in Arm B, AH will be performed on Day-5 blastocysts prior to trophectoderm biopsy. A total of approximately 200 IVF cycles, involving around 650 embryos, will be included. Randomization will be conducted using block randomization. The primary outcome is the proportion of aneuploid blastocysts identified by next-generation sequencing (NGS). Secondary outcomes include blastocyst morphology (ICM, TE, expansion), biopsy efficiency, and correlation between morphological parameters and genetic outcomes.
All procedures are part of the routine IVF-PGT workflow, and no additional risks to patients are introduced beyond standard care. The trial has been approved by the Institutional Review Board of 16A Ha Dong General Hospital.
Interventions
- Procedure Assisted Hatching
Laser-assisted zona drilling performed either on Day-3 or Day-5 of culture, depending on randomization arm.
Primary outcome measures
- Proportion of aneuploid blastocysts [Time frame: At the time of trophectoderm biopsy and PGT-A result (Day 5-6 of embryo culture).]
Secondary outcome measures (2)
- Blastocyst morphology (ICM and TE grade) [Time frame: Day 5-6 of culture]
- Mosaicism rate [Time frame: Day 5-6 of culture]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- Center for Reproductive Support, 16A Ha Dong General Hospital — Hanoi
Publications
- ESHRE Working Group on Recurrent Implantation Failure; Cimadomo D, de Los Santos MJ, Griesinger G, Lainas G, Le Clef N, McLernon DJ, Montjean D, Toth B, Vermeulen N, Macklon N. ESHRE good practice recommendations on recurrent implantation failure. Hum Reprod Open. 2023 Jun 15;2023(3):hoad023. doi: 10.1093/hropen/hoad023. eCollection 2023. PMID 37332387
- McArthur SJ, Leigh D, Marshall JT, de Boer KA, Jansen RP. Pregnancies and live births after trophectoderm biopsy and preimplantation genetic testing of human blastocysts. Fertil Steril. 2005 Dec;84(6):1628-36. doi: 10.1016/j.fertnstert.2005.05.063. PMID 16359956
- Capalbo A, Rienzi L, Cimadomo D, Maggiulli R, Elliott T, Wright G, Nagy ZP, Ubaldi FM. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screened blastocysts. Hum Reprod. 2014 Jun;29(6):1173-81. doi: 10.1093/humrep/deu033. Epub 2014 Feb 26. PMID 24578475
Identifiers
NCT: NCT07154875 · AH-PGTA-2025 · 16A-IRB-2025