Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 4
- 主要终点
- Predictive Value of Aneuploidy Screening
研究概览
简要总结
The primary objective of this study is to determine the predictive value of preimplantation genetic screening (PGS) as a marker of embryonic competence. Secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in assisted reproductive technology (ART) cycles.
详细描述
Patients participating in the study will undergo a routine in vitro fertilization cycle. Trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be analyzed till the clinical outcome has been determined. The single, morphologically best embryo available will be selected for transfer. All clinical and laboratory care is identical to that of which subjects would receive if they were not participating in the study. This includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Couples electing embryonic aneuploidy screening (PGS)
- •Couples electing single embryo transfer
排除标准
- •Any prior failed IVF cycle
- •Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- •Diagnosis of chronic endometritis
- •Maximum day 3 FSH level of 12 or higher
- •Anti-mullerian hormone level less than 0.5 g/mL, tested within previous year
- •Total basal antral follicle count less than 8 follicles
- •Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- •BMI <18.5 or > 35
- •Personal history of recurrent pregnancy loss (two or more pregnancy losses)
- •Use of oocyte donation
- •Use of gestational carrier
- •Medical condition predisposing patient to high risk pregnancy
- •Use of surgical procedures to obtain sperm
- •Presence of hydrosalpinges that communicate with endometrial cavity
- •Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
- •Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
结局指标
主要结局
Predictive Value of Aneuploidy Screening
时间窗: approximately 1 month post clinical outcome
Determine confidence intervals that a euploid embryo will implant, an aneuploid embryo will not implant, and the likelihood of mosaic and segmental aneuploid embryos implanting and describe their outcomes.
次要结局
未报告次要终点