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NCT Number: NCT06377917

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.

Recruiting

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Associates of New Jersey

Marlton, New Jersey, 08053, United States

Location status: Recruiting

Location contact

Caroline Zuckerman, BS, RN

CONTACT

[email protected]

19736562841

Christine V Whitehead, MS, BSN, RN

CONTACT

[email protected]

19736562841

Jason Fransiak, MD

PRINCIPAL_INVESTIGATOR

Kevin Lambrese, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for participants:

  • 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.

Exclusion criteria

for participants:

  • 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

Treatment and study plan

Laser Assisted Hatching

Other

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

Primary outcomes

  1. Blastulation Rate

    Time frame: 1 week after vaginal oocyte retrieval (VOR)

    Blastulation rate per 2 pronuclei (PN) in each group

Secondary outcomes

  1. Embryo morphologic grade

    Time frame: 1 week post VOR

    Gardner and Modified Gardner grading system will be used

  2. Timing of blastulation

    Time frame: 1 week post VOR

    proportion of blastocysts that blastulate on day 5,6 or 7

  3. Aneuploidy rate

    Time frame: 2 weeks post blastulation

    Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results

  4. Positive pregnancy rate

    Time frame: approximately 9 days post embryo transfer

    proportion of positive pregnancy tests per embryo transfer

  5. Sustained implantation rate

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

    proportion of patients discharged with presence of a fetal heartbeat

  6. Pregnancy loss rate

    Time frame: approximately 1-2 months post initial bHCG

    proportion of pregnancy patients who experience a loss of pregnancy

  7. Live birth rate

    Time frame: approximately 40 weeks gestation or 7 months post discharge

    proportion of patients who deliver a live born infant

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Zuckerman, BS, RN

CONTACT

[email protected]

19736562841

Christine V Whitehead, MS, BSN, RN

CONTACT

[email protected]

19736562841

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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