Investigating Micro-Manipulation Procedures for Assisted Hatching Timing (IMPACT)

The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: Laser Assisted Hatching

Detailed Description

The proposed study aims to perform a split cohort study where each patient's cohort of fertilized zygotes, (two pronuclei or 2PNs) is split into two groups and randomized, thus allowing each patient to serve as their own control and decreasing confounding variables. Half of the cohort will proceed with the current standard of day 3 or cleavage assisted hatching and the other half of the cohort will receive the sequential hatching and trophectoderm biopsy procedure at the blastocyst stage of embryo development.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Zuckerman, BS, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com
• Study Contact Backup: Name: Christine V Whitehead, MS, BSN, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com

Study Locations

• United States
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Recruiting
      • Reproductive Medicine Associates of new Jersey
      • Contact: Caroline Zuckerman, BS, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com
      • Contact: Christine V Whitehead, MS, BSN, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com
      • Principal Investigator: Jason Fransiak, MD
      • Principal Investigator: Kevin Lambrese, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Laser Assisted Hatching; Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Experimental: Blastocyst Stage Assisted Hatching (AH); Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.	Other: Laser Assisted Hatching; Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastulation Rate	Blastulation rate per 2 pronuclei (PN) in each group	1 week after vaginal oocyte retrieval (VOR)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embryo morphologic grade	Gardner and Modified Gardner grading system will be used	1 week post VOR
Timing of blastulation	proportion of blastocysts that blastulate on day 5,6 or 7	1 week post VOR
Aneuploidy rate	Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results	2 weeks post blastulation
Positive pregnancy rate	proportion of positive pregnancy tests per embryo transfer	approximately 9 days post embryo transfer
Sustained implantation rate	proportion of patients discharged with presence of a fetal heartbeat	8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer
Pregnancy loss rate	proportion of pregnancy patients who experience a loss of pregnancy	approximately 1-2 months post initial bHCG
Live birth rate	proportion of patients who deliver a live born infant	approximately 40 weeks gestation or 7 months post discharge

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Jason Fransiak, MD, Reproductive Medicine Associates of new Jersey

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2304-BRG-057-JF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No