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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cleavage Stage Assisted Hatching (AH) | Other | Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser. |
|
| Blastocyst Stage Assisted Hatching (AH) | Experimental | Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Assisted Hatching | Other | Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blastulation Rate | Blastulation rate per 2 pronuclei (PN) in each group | 1 week after vaginal oocyte retrieval (VOR) |
| Measure | Description | Time Frame |
|---|---|---|
| Embryo morphologic grade | Gardner and Modified Gardner grading system will be used | 1 week post VOR |
| Timing of blastulation | proportion of blastocysts that blastulate on day 5,6 or 7 |
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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:
BMI <38
Patients who desire to transfer the best quality embryo for their embryo transfer.
Exclusion Criteria for participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine V Whitehead, MS, BSN, RN | Contact | 19736562841 | clinicalresearchteam@ivirma.com | |
| Caroline Zuckerman, BS, RN | Contact | 19736562841 | clinicalresearchteam@ivirma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Fransiak, MD | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Recruiting | Marlton | New Jersey | 08053 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 1 week post VOR |
| Aneuploidy rate | Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results | 2 weeks post blastulation |
| Positive pregnancy rate | proportion of positive pregnancy tests per embryo transfer | approximately 9 days post embryo transfer |
| Sustained implantation rate | proportion of patients discharged with presence of a fetal heartbeat | 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer |
| Pregnancy loss rate | proportion of pregnancy patients who experience a loss of pregnancy | approximately 1-2 months post initial bHCG |
| Live birth rate | proportion of patients who deliver a live born infant | approximately 40 weeks gestation or 7 months post discharge |