Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
- Conditions
- Infertility
- Interventions
- Other: Laser Assisted Hatching
- Registration Number
- NCT06377917
- Lead Sponsor
- Reproductive Medicine Associates of New Jersey
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cleavage Stage Assisted Hatching (AH) Laser Assisted Hatching Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser. Blastocyst Stage Assisted Hatching (AH) Laser Assisted Hatching Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.
- Primary Outcome Measures
Name Time Method Blastulation Rate 1 week after vaginal oocyte retrieval (VOR) Blastulation rate per 2 pronuclei (PN) in each group
- Secondary Outcome Measures
Name Time Method Embryo morphologic grade 1 week post VOR Gardner and Modified Gardner grading system will be used
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
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
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
Positive pregnancy rate approximately 9 days post embryo transfer proportion of positive pregnancy tests per embryo transfer
Trial Locations
- Locations (1)
Reproductive Medicine Associates of New Jersey
🇺🇸Marlton, New Jersey, United States