NCT02268786已完成不适用
Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 661
- 试验地点
- 72
- 主要终点
- Ongoing Pregnancy
研究概览
简要总结
The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing IVF
- •At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development
排除标准
- •History of more than two prior implantation failure following IVF
- •History of more than one miscarriage of viable pregnancy
- •One or both partners known to be carrier(s) of a chromosomal abnormality
- •Known genetic carrier couple and/or one or both partners carrier of a known autosomal dominant disorder
- •Any other non-study related preimplantation genetic testing
- •Use of donor oocytes
- •Use of gestational carrier (surrogate or donor egg recipient).
- •Severe oligospermia (<1,000,000 sperm/ml); Surgical Sperm Retrieval for reasons other than post-vasectomy and CAVD
- •Low ovarian reserve with (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and/or (AMH) <7 pmol/L (or <1 ng/ml)
- •Gender selection cycles
- •Concurrent participation in another clinical trial
结局指标
主要结局
Ongoing Pregnancy
时间窗: Gestational Age of 20 Weeks
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
次要结局
未报告次要终点
研究者
研究点 (72)
Loading locations...
相似试验
Unknown
1 期
Blastocyst Euploidy Assessment and Conditioned embryO traNsferInfertilityNCT02353364Chinese PLA General Hospital1,000
已完成
不适用
Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe FactorEmbryo AneuploidiesImplantation RatesInfertilityNCT01571076Igenomix240
Unknown
3 期
The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation ProtocolEmbryo's Genetic and Chromosomal QualityNCT01636505European Hospital200
招募中
不适用
Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy EmbryosWomen Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving WomenNCT04280757Wael Elbanna Clinic420
已完成
不适用
Predictive Value of Embryonic TestingInfertilityNCT03604107Reproductive Medicine Associates of New Jersey237