Preimplantion Genetic Testing for Aneuploidies (PGT-A) in Patients With Recurrent Implantation Failure: a Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- OPR
研究概览
简要总结
Assessing whether Preimplantation Genetic Testing for Aneuploidy (PGT-A) can increase the ongoing pregnancy rate per transferred embryo and can decrease the time to pregnancy and miscarriage rate in patients with Recurrent Implantation Failure (RIF)
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with recurrent implantation failure (previous transfer of least 4 good quality embryos in at least 3 fresh or frozen cycles)
- •BMI < 35
- •Normal hysteroscopy
排除标准
- •thin endometrium in previous cycles (<6mm), endometriosis ASRM score III-IV, premature ovarian failure (POF, Bologna criteria), abnormal karyotype, donor oocytes or embryos, PGT-M
研究组 & 干预措施
PGT-A group
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage (day 5/6), TE biopsy, vitrification of all embryos in the blastocyst stage, PGT-A by NGS and finally embryo transfer of genetically normal embryos in cumulative frozen-thawed embryo transfer cycles
干预措施: PGT-A (Procedure)
Control group
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage, fresh embryo transfer of the morphologically best embryo on day 5/6, vitrification of supernumerary embryos and embryo transfer in cumulative frozen-thawed embryo transfer cycles if not pregnant from the fresh cycle.
干预措施: Control (Procedure)
结局指标
主要结局
OPR
时间窗: at 20 weeks gestational age
Ongoing pregnancy rate per embryo transfer
次要结局
- IR(2 weeks)
研究者
Brecht Geysenbergh
Principal Investigator
Universitaire Ziekenhuizen KU Leuven