The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Blastulation Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •FSH ≤ 12IU/L
- •Patients who desire to transfer the best quality embryo for their embryo transfer.
排除标准
- •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
研究组 & 干预措施
Cleavage Stage Assisted Hatching (AH)
Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser.
干预措施: Laser Assisted Hatching (Other)
Blastocyst Stage Assisted Hatching (AH)
Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.
干预措施: Laser Assisted Hatching (Other)
结局指标
主要结局
Blastulation Rate
时间窗: 1 week after vaginal oocyte retrieval (VOR)
Blastulation rate per 2 pronuclei (PN) in each group
次要结局
- Embryo morphologic grade(1 week post VOR)
- Pregnancy loss rate(approximately 1-2 months post initial bHCG)
- Live birth rate(approximately 40 weeks gestation or 7 months post discharge)
- Timing of blastulation(1 week post VOR)
- Aneuploidy rate(2 weeks post blastulation)
- Sustained implantation rate(8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer)
- Positive pregnancy rate(approximately 9 days post embryo transfer)