Clinical trial NCT06377917: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
Official title: The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blastulation Rate
timeFrame: 1 week after vaginal oocyte retrieval (VOR)
Secondary outcomes:
measure: Embryo morphologic grade
timeFrame: 1 week post VOR
measure: Timing of blastulation
timeFrame: 1 week post VOR
measure: Aneuploidy rate
timeFrame: 2 weeks post blastulation
measure: Positive pregnancy rate
timeFrame: approximately 9 days post embryo transfer
measure: Sustained implantation rate
timeFrame: 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer
measure: Pregnancy loss rate
timeFrame: approximately 1-2 months post initial bHCG
measure: Live birth rate
timeFrame: approximately 40 weeks gestation or 7 months post discharge
Other outcomes:
Locations:
city: Marlton
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Jason Fransiak, MD
role: PRINCIPAL_INVESTIGATOR
References: