NCT06377917

Brief Summary

This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Apr 2025May 2027

First Submitted

Initial submission to the registry

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

April 17, 2024

Last Update Submit

February 4, 2025

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Blastulation Rate

    Blastulation rate per 2 pronuclei (PN) in each group

    1 week after vaginal oocyte retrieval (VOR)

Secondary Outcomes (7)

  • Embryo morphologic grade

    1 week post VOR

  • Timing of blastulation

    1 week post VOR

  • Aneuploidy rate

    2 weeks post blastulation

  • Positive pregnancy rate

    approximately 9 days post embryo transfer

  • Sustained implantation rate

    8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer

  • +2 more secondary outcomes

Study Arms (2)

Cleavage Stage Assisted Hatching (AH)

OTHER

Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser.

Other: Laser Assisted Hatching

Blastocyst Stage Assisted Hatching (AH)

EXPERIMENTAL

Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.

Other: Laser Assisted Hatching

Interventions

Laser Assisted HatchingOTHER

Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.

Blastocyst Stage Assisted Hatching (AH)Cleavage Stage Assisted Hatching (AH)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo
  • \<4 2PNs prior to randomization
  • Female partners age \<42 years old at start of VOR cycle
  • Normal ovarian reserve:
  • AMH ≥ 1.2 ng/mL
  • AFC ≥ 8
  • FSH ≤ 12IU/L
  • BMI \<38
  • Patients who desire to transfer the best quality embryo for their embryo transfer.

You may not qualify if:

  • All patients who do not voluntarily give their written consent for participation
  • Patients with a prior failed IVF cycle - defined as no blastocysts
  • Patients with a history of more than one failed euploid embryo transfer
  • Donor oocyte cycles
  • Gestational Carriers
  • Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
  • Use of surgical procedures to obtain sperm
  • Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
  • Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
  • Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis than standard PGT-A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jason Fransiak, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine V Whitehead, MS, BSN, RN

CONTACT

19736562841clinicalresearchteam@ivirma.com

Caroline Zuckerman, BS, RN

CONTACT

19736562841clinicalresearchteam@ivirma.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

April 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)