NCT06377917 · Reproductive Medicine Associates of New Jersey
Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
(IMPACT)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- FSH ≤ 12IU/L
- 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
Where
- Marlton, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations