Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Impact of next generation sequencing on the embryos produced from IVF on implantation rates
研究概览
简要总结
To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy. All viable blastocysts will be biopsied and cryopreserved for future transfer. After the final embryo is cryopreserved, patients will be randomized to either the intervention group or the control group. Patients and doctors are blinded to the randomization until study completion. A Double Embryo Transfer (DET) will be performed with either screened or unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in cases where only one embryo is available for transfer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patient undergoing IVF/CCS (no PGD banking)
- •Patient meets ASRM guidelines for Double Embryo Transfer (DET)
- •Donor Sperm OK
- •AMH ≥ 1.2
- •Max 1 prior failed IVF cycle for patients 35-45 years old
- •Patient <35 years old MUST have 1 prior failed IVF cycle
排除标准
- •Chronic endometrial insufficiency
- •Use of oocyte donor or gestational carriers
- •Medical contraindications to Double Embryo Transfer (DET)
- •Male Factor (<100,000 sperm or surgical sperm)
- •Communicating hydrosalpinx (on HSG)
- •Single gene disorders or sex selection
研究组 & 干预措施
Comprehensive Chromosome Screening
Trophectoderm biopsy will be performed on all blastocysts and CCS via next generation sequencing screening performed on biopsy samples. Patients will proceed with a single or double embryo transfer of the one or two morphologically best euploid embryos
干预措施: Comprehensive Chromosome Screening (Other)
No Comprehensive Chromosome Screening
The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos.
干预措施: Morphologically Best (Other)
结局指标
主要结局
Impact of next generation sequencing on the embryos produced from IVF on implantation rates
时间窗: 2 years
To evaluate the benefits, if any, of using next generation sequencing based Comprehensive Chromosome Screening (CCS) in the selection of embryos for transfer during clinical IVF cycles
次要结局
- Delivery Rates(2 years)