NCT07154875

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jun 2025Jun 2028

Study Start

First participant enrolled

June 14, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2028

Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

August 27, 2025

Last Update Submit

September 3, 2025

Conditions

Infertility; In Vitro Fertilization; Embryo Development

Keywords

Assisted hatching, Day-3 vs Day-5, Blastocyst morphology, Trophectoderm biopsy, PGT-A, Aneuploidy, Mosaicism

Outcome Measures

Primary Outcomes (1)

  • Proportion of aneuploid blastocysts

    Percentage of blastocysts diagnosed as aneuploid by next-generation sequencing (NGS) after trophectoderm biopsy in each group (Day-3 vs Day-5 AH).

    At the time of trophectoderm biopsy and PGT-A result (Day 5-6 of embryo culture).

Secondary Outcomes (2)

  • Blastocyst morphology (ICM and TE grade)

    Day 5-6 of culture

  • Mosaicism rate

    Day 5-6 of culture

Other Outcomes (1)

  • Correlation between blastocyst morphology and genetic outcome

    Day 5-6 of culture (at the time of trophectoderm biopsy and PGT-A result)

Study Arms (2)

Day-3 Assisted Hatching

EXPERIMENTAL

Embryos undergo laser-assisted zona drilling on Day-3. Embryos are then cultured to Day-5 and biopsied for PGT-A.

Procedure: Assisted Hatching

Day-5 Assisted Hatching

EXPERIMENTAL

Embryos are cultured without zona drilling until Day-5. Laser-assisted hatching is performed immediately before trophectoderm biopsy for PGT-A.

Procedure: Assisted Hatching

Interventions

Assisted HatchingPROCEDURE

Laser-assisted zona drilling performed either on Day-3 or Day-5 of culture, depending on randomization arm.

Also known as: Laser-assisted hatching, LAH, Zona drilling, AH
Day-3 Assisted HatchingDay-5 Assisted Hatching

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproductive Support, 16A Ha Dong General Hospital

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Related Publications (3)

  • 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: 37332387BACKGROUND

  • 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: 16359956BACKGROUND

  • 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: 24578475BACKGROUND

Related Links

MeSH Terms

Conditions

InfertilityAneuploidy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesChromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ngan M Hoang, MSc

    Center for Reproductive Support, 16A Ha Dong General Hospital

    PRINCIPAL INVESTIGATOR

  • Tao D Nguyen, MD, PhD, Professor

    Center for Reproductive Support, 16A Ha Dong General Hospital

    STUDY CHAIR

Central Study Contacts

HOANG M NGAN, MSc

CONTACT

0936749290hmngan3590@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The PGT-A analysts evaluating the NGS results were blinded to the assisted hatching timing.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Embryos randomized to receive assisted hatching on Day-3 (Arm A) or Day-5 (Arm B) prior to trophectoderm biopsy.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Embryologist, Head of IVF Laboratory

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 4, 2025

Study Start

June 14, 2025

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

June 14, 2028

Last Updated

September 5, 2025

Record last verified: 2025-09

Locations

VN(1)