Day-3 versus Day-5 assisted hatching for IVF embryos with PGT-A
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
This trial tests whether doing assisted hatching on Day 3 or Day 5 helps embryos from people having IVF with PGT-A.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | 16A Ha Dong General Hospital Academic / other |
| Locations | 1 site (Hanoi, Hanoi) |
| Trial ID | NCT07154875 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll about 200 IVF cycles (approximately 650 embryos) and randomize embryos to receive assisted hatching on either Day 3 or Day 5 prior to trophectoderm biopsy. The primary outcome is the proportion of aneuploid blastocysts measured by next-generation sequencing, with secondary outcomes including blastocyst morphology, expansion stage, biopsy efficiency, and the correlation between morphology and genetic results. Randomization uses block methods and procedures follow standard IVF-PGT workflows so no additional risk beyond routine care is introduced. The protocol is approved by the Institutional Review Board of 16A Ha Dong General Hospital and will be conducted at their Center for Reproductive Support in Hanoi.
Who should consider this trial
Good fit: People undergoing IVF with PGT-A aged 20–45 years (donor cycles use donor age) with AMH 1–10 ng/mL, AFC ≥5, using ejaculated sperm and standard stimulation protocols are the intended participants.
Not a fit: Patients not undergoing PGT-A, those needing PGT-M or PGT-SR, cycles using surgically retrieved sperm or advanced sperm selection, patients with PCOS by Rotterdam criteria, or those with very poor ovarian reserve are excluded and unlikely to receive benefit from this comparison.
Why it matters
Potential benefit: If successful, the findings could help labs choose the best timing for assisted hatching, potentially improving embryo selection and increasing the chance of transferring euploid embryos and achieving pregnancy.
How similar studies have performed: Prior studies of assisted hatching have shown mixed results and timing effects on genetic outcomes are not well established, so a randomized comparison specifically within PGT-A cycles is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hanoi, Hanoi
- Center for Reproductive Support, 16A Ha Dong General Hospital — Hanoi, Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Ngan M Hoang, MSc — Center for Reproductive Support, 16A Ha Dong General Hospital
- Study coordinator: HOANG M NGAN, MSc
- Email: hmngan3590@gmail.com
- Phone: 0936749290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.