Status:
RECRUITING
Day-3 vs Day-5 Assisted Hatching: Impact on Blastocyst Morphology and PGT-A Outcomes
Lead Sponsor:
Hoang Minh Ngan
Collaborating Sponsors:
16A Ha Dong General Hospital
Conditions:
Infertility; In Vitro Fertilization; Embryo Development
Eligibility:
FEMALE
20-45 years
Phase:
NA
Brief 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 te...
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 em...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 14 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07154875
Start Date
June 14 2025
End Date
June 14 2028
Last Update
September 5 2025
Active Locations (1)
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1
Center for Reproductive Support, 16A Ha Dong General Hospital
Hanoi, Hanoi, Vietnam, 100000