Recruiting

Assisted Hatching

Sponsor:

Reproductive Medicine Associates of New Jersey

Code:

NCT06377917

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Interventions

Laser Assisted Hatching

Study Details

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.

Conditions

Infertility

Study ID

NCT06377917

Start date

May 31, 2026

Status verified date

Jun, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Inclusion Criteria for participants:

1. Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo
2. <4 2PNs prior to randomization
3. Female partners age <42 years old at start of VOR cycle
4. Normal ovarian reserve:

1. AMH ≥ 1.2 ng/mL
2. AFC ≥ 8
3. FSH ≤ 12IU/L
5. BMI <38
6. Patients who desire to transfer the best quality embryo for their embryo transfer.

Exclusion Criteria for participants:

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Cleavage Stage Assisted Hatching (AH)

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

experimental: Blastocyst Stage Assisted Hatching (AH)

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

Interventions

Laser Assisted Hatching

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

Primary outcome measure

  • Blastulation Rate [ Time Frame: 1 week after vaginal oocyte retrieval (VOR) ]

Central Contacts and Locations

Central contacts

Christine V Whitehead, MS, BSN, RN

19736562841clinicalresearchteam@ivirma.com

Locations

Reproductive Medicine Associates of New Jersey

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Christine V Whitehead, MS, BSN, RN

19736562841clinicalresearchteam@ivirma.com

Principal Investigator:

Jason Fransiak, MD

More Information

Sponsor

Reproductive Medicine Associates of New Jersey

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reproductive Medicine Associates of New Jersey on 2026-06-03.