GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40 years of age.
详细描述
In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF center will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants.
Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center.
In the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known.
In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation information will be handled by embryology team at BIVF.
入排标准
- 年龄范围
- 35 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing IVF of between 35 and 40 years of age at IVF cycle start
- •Utilization of Intracytoplasmic Sperm Injection ICSI (recommended) or ---Traditional IVF
- •Utilization of ejaculated or testicular sperm
- •Utilization of autologous or donor sperm
- •All Controlled Ovarian Hyperstimulation (COH) protocols
排除标准
- •Utilization of donor oocytes
- •Utilization of gestational carrier
- •Recurrent Pregnancy Loss (RPL) defined as ≥ 3 consecutive miscarriages
- •Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers
- •Preimplantation genetic testing for monogenic/single gene disorders (PGT-M)
- •Translocation carriers
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: Up to 2 years
The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer.
次要结局
- Miscarriage Rate(Up to 2 years)