Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

Official title

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

Overview

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.

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.

Interventions

• Other Laser Assisted Hatching
  Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.

Primary outcome measures

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

Secondary outcome measures (7)

• Embryo morphologic grade [Time frame: 1 week post VOR]
• Timing of blastulation [Time frame: 1 week post VOR]
• Aneuploidy rate [Time frame: 2 weeks post blastulation]
• Positive pregnancy rate [Time frame: approximately 9 days post embryo transfer]
• Sustained implantation rate [Time frame: 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer]
• Pregnancy loss rate [Time frame: approximately 1-2 months post initial bHCG]
• Live birth rate [Time frame: approximately 40 weeks gestation or 7 months post discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

United States · 1 center

• Reproductive Medicine Associates of New Jersey — Marlton

Identifiers

NCT: NCT06377917 · 2304-BRG-057-JF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗