An RCT Evaluating the Implantation Potential of Vitrified Embryos Screened by Next Generation Sequencing Following Trophectoderm Biopsy, Versus Vitrified Unscreened Embryos in Good Prognosis Patients Undergoing IVF
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clinical pregnancy
研究概览
简要总结
This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).
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
- None
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at least 2 blastocysts suitable for biopsy on day 5 of embryo development remaining after fresh transfer
- •willing and able to give informed consent
- •infertility as an indication for IVF/ICSI
- •first or second IVF/ICSI cycle
- •patients willing to accept single embryo transfer
- •BMI range 18 to 35 kg/m2
排除标准
- •any type of genetic abnormality or family history of genetic abnormality in subject or partner
- •any other non-study related preimplantation genetic testing
- •three or more clinical miscarriages (recurrent pregnancy loss, RPL)
- •recurrent implantation failure (RIF): no positive β-hCG after transfer (fresh IVF/ICSI cycle or frozen) with no less than 6 cleavage stage embryos or no less than 4 blastocysts, all of good quality and of appropriate developmental stage
- •severe endometriosis
- •abnormal uterine cavity
- •cycles requiring surgical sperm recovery procedures, total asthenozoospermia and/or globozoospermia
- •treatment involving use of donor oocytes or use of gestational carrier
研究组 & 干预措施
no PGS (no genetic screening)
Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment
PGS (genetic screening)
Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment
干预措施: Preimplantation Genetic Screening (Diagnostic Test)
结局指标
主要结局
Clinical pregnancy
时间窗: At 7 - 8 gestational weeks
Rate of clinical pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after transfer of embryo in PGS arm versus in no PGS arm.
次要结局
- Clinical miscarriage(At 7 - 16 gestational weeks)
- Live birth(At delivery)
- Biochemical pregnancy(At 7 -8 gestational weeks)
- Aneuploidy(At delivery)