Infertility
Conditions
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.
Interventions
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastulation Rate | 1 week after vaginal oocyte retrieval (VOR) | Blastulation rate per 2 pronuclei (PN) in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Embryo morphologic grade | 1 week post VOR | Gardner and Modified Gardner grading system will be used |
| Timing of blastulation | 1 week post VOR | proportion of blastocysts that blastulate on day 5,6 or 7 |
| Aneuploidy rate | 2 weeks post blastulation | Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results |
| Positive pregnancy rate | approximately 9 days post embryo transfer | proportion of positive pregnancy tests per embryo transfer |
| Sustained implantation rate | 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer | proportion of patients discharged with presence of a fetal heartbeat |
| Pregnancy loss rate | approximately 1-2 months post initial bHCG | proportion of pregnancy patients who experience a loss of pregnancy |
| Live birth rate | approximately 40 weeks gestation or 7 months post discharge | proportion of patients who deliver a live born infant |
Countries
United States
Contacts
CONTACTChristine V Whitehead, MS, BSN, RN
CONTACTCaroline Zuckerman, BS, RN
PRINCIPAL_INVESTIGATORJason Fransiak, MD
Reproductive Medicine Associates of New Jersey
Outcome results
None listed