Clinical Study, International, Multicentre, Prospective, Randomised, Interventional and Controlled, Comparing Fresh Embryo Transfer (ET) Versus Frozen Embryo Transfer (FET) and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Analysis) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Igenomix
- 入组人数
- 569
- 试验地点
- 30
- 主要终点
- Live birth delivery rate
研究概览
简要总结
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
详细描述
This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer.
A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.
- •Age ≤ 37 years
- •BMI: 18.5 to 30
- •Normal ovarian reserve (AFC ≥ 8; FSH < 8)
- •The most appropriated stimulation protocol will be decided by their doctor.
- •Blastocyst transfer (on day 5 or 6)
- •Blastocyst vitrification with open protocols (Cryotop, Cryoleaf, or Cryolock) or closed protocols (Cryotip or CBSStraw.)
- •Any pathology affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx affecting the endometrial cavity must be previously operated.
排除标准
- •Patients with recurrent miscarriages (> 2 previous biochemical pregnancies or > 2 spontaneous miscarriages)
- •Patients with a severe male factor (spermatozoa < 2 million/ml)
- •Patients with implantation failure (>3 failed cycles with good quality embryos)
- •Post-Randomization Exclusion Criteria:
- •Endogenous progesterone level ≥ 1,5 ng/ml at the day of hCG administration in all groups.
- •Absence of blastocysts (day 5 or 6) for embryo transfer.
- •Risk of ovarian hyperstimulation syndrome in any of the three groups and therefore a clinical indication to cancel the transfer cycle where the stimulated patient is from group A (ET).
- •Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those cycles in which PGT-A was performed will be included
研究组 & 干预措施
Personalized embryo transfer (pET)
Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and an endometrial biopsy in a substituted cycle after 5 days (around 120 hours) of progesterone administration. The ERA test will determine the window of implantation (WOI) for each patient and will recommend the best time for embryo transfer thereby increasing the chances of a successful outcome. In some specific cases (≤ 10%) a second biopsy will be required to help the bioinformatic predictor to ensure the most appropriated moment for the embryo transfer. In a different cycle, patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI and vitrified. In a subsequent cycle, following the ERA result, a personalized embryo transfer (pET) will be carried out following the same conditions in which the ERA test was obtained, using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage)
干预措施: personalized Embryo Transfer (pET) (Other)
Frozen embryo transfer (FET)
Patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In a subsequent cycle, following hormone replacement therapy (HRT), a frozen embryo transfer (FET) will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).
干预措施: Frozen Embryo Transfer (FET) (Other)
Fresh embryo transfer (ET)
Patients will undergo a controlled ovarian stimulation cycle (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In the same cycle, a fresh embryo transfer will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).
干预措施: Fresh Embryo Transfer (ET) (Other)
结局指标
主要结局
Live birth delivery rate
时间窗: 40 weeks
Percentage of deliveries that resulted in at least one live birth per embryo transfer.
次要结局
- Pregnancy rate(20 weeks)
- Biochemical pregnancies(20 weeks)
- Clinical miscarriages(20 weeks)
- Cumulative live birth delivery rate(12 months)
- Implantation rate(12 weeks)
- Ectopic pregnancies(20 weeks)
- Cumulative pregnancy rate(12 months)
- Cumulative implantation rate(12 months)
研究者
Carlos Simon
Scientific Director IGENOMIX; Gynaecologist IVI Valencia
Instituto Valenciano de Infertilidad, IVI VALENCIA