Day-3 vs Day-5 Assisted Hatching: Impact on Blastocyst Morphology and PGT-A Outcomes
NCT ID: NCT07154875
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-06-14
2028-06-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Day-3 Assisted Hatching
Embryos undergo laser-assisted zona drilling on Day-3. Embryos are then cultured to Day-5 and biopsied for PGT-A.
Assisted Hatching
Laser-assisted zona drilling performed either on Day-3 or Day-5 of culture, depending on randomization arm.
Day-5 Assisted Hatching
Embryos are cultured without zona drilling until Day-5. Laser-assisted hatching is performed immediately before trophectoderm biopsy for PGT-A.
Assisted Hatching
Laser-assisted zona drilling performed either on Day-3 or Day-5 of culture, depending on randomization arm.
Interventions
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Assisted Hatching
Laser-assisted zona drilling performed either on Day-3 or Day-5 of culture, depending on randomization arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
20 Years
45 Years
FEMALE
No
Sponsors
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16A Ha Dong General Hospital
OTHER
Hoang Minh Ngan
OTHER
Responsible Party
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Hoang Minh Ngan
Principal Investigator, Embryologist, Head of IVF Laboratory
Principal Investigators
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Ngan M Hoang, MSc
Role: PRINCIPAL_INVESTIGATOR
Center for Reproductive Support, 16A Ha Dong General Hospital
Tao D Nguyen, MD, PhD, Professor
Role: STUDY_CHAIR
Center for Reproductive Support, 16A Ha Dong General Hospital
Locations
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Center for Reproductive Support, 16A Ha Dong General Hospital
Hanoi, Hanoi, Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Related Links
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Official website of 16A Ha Dong General Hospital - Center for Reproductive Support
Other Identifiers
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16A-IRB-2025
Identifier Type: OTHER
Identifier Source: secondary_id
AH-PGTA-2025
Identifier Type: -
Identifier Source: org_study_id
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