Efficacy of a Non-Invasive Endometrial Receptivity Prediction Model Based on Peripheral Blood miRNA Signatures During the Peri-Implantation Period in Improving IVF Outcomes in Patients With Unexplained Recurrent Implantation Failure: A Prospective, Single-Blind, Two-Arm, Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 546
- 主要终点
- Implantation rate per embryo transferred, assessed by counting gestational sacs on ultrasound.
研究概览
简要总结
The goal of this clinical trial aims to investigate whether a non-invasive implantation window prediction model, constructed based on characteristic changes in peripheral blood miRNAs during the peri-implantation period, can improve pregnancy outcomes in patients with unexplained recurrent implantation failure undergoing frozen embryo transfer. Researchers will compare the clinical pregnancy outcomes between individualized embryo transfer guided by implantation window results and conventional embryo transfer, to observe whether implantation window-guided individualized embryo transfer can improve the clinical efficacy for patients with recurrent implantation failure (RIF). Participants will complete implantation window testing as required by the study protocol, undergo randomization and blinding, and proceed with embryo transfer according to their assigned group.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with unexplained recurrent implantation failure (RIF) meeting the diagnostic criteria for RIF: adult women under 40 years old who have failed to achieve clinical pregnancy after 3 embryo transfer cycles; or after transferring at least 3 high-quality embryos.
- •Definition of high-quality embryos: Day 3 embryos (with a cell count ≥7 and fragmentation rate <10%) and blastocysts (≥3BB).
- •Female BMI: 18.5-25 kg/m².
- •Endometrial thickness ≥7 mm during the embryo transfer cycle.
- •Women planning to undergo frozen-thawed embryo transfer (FET) of blastocysts following in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
- •Signed informed consent form.
排除标准
- •Known causes of embryo implantation failure, such as infections, reproductive tract malformations, uterine cavity factors, adenomyosis or endometriosis, autoimmune system diseases (diagnosed by immunology department), hydrosalpinx, etc.
- •Couples with chromosomal abnormalities (excluding chromosomal polymorphisms) or familial genetic disorders in either or both partners.
- •Women with a history of recurrent miscarriage.
- •Women with contraindications to pregnancy or assisted reproductive technology.
研究组 & 干预措施
Standard Embryo Transfer Group
Individualized Embryo Transfer Group
干预措施: Non-invasive endometrial receptivity prediction model guides personalized embryo transfer for patients with recurrent implantation failure (RIF). (Diagnostic Test)
结局指标
主要结局
Implantation rate per embryo transferred, assessed by counting gestational sacs on ultrasound.
时间窗: From the day of embryo transfer until the completion of the first ultrasound assessment (typically at 35 days ± 7 days after transfer).
Implantation rate is defined as the number of gestational sacs observed on ultrasound divided by the total number of embryos transferred. It will be expressed as a percentage: (Total number of gestational sacs / Total number of embryos transferred) × 100%. Assessment will occur approximately 35 days after embryo transfer.
次要结局
- Proportion of patients with abnormal endometrial receptivity, as assessed by dynamic changes in peripheral blood microRNA levels 5 days after ovulation.(From the day of ovulation trigger until the completion of microRNA sample collection and analysis (within 5 to 7 days post-trigger).)
- Clinical pregnancy rate per embryo transfer, confirmed by ultrasound visualization of gestational sac and fetal heartbeat.(From the day of embryo transfer until the confirmation of clinical pregnancy by ultrasound (assessed at approximately 35 days ± 7 days after embryo transfer).)
- Ongoing Pregnancy Rate per embryo transfer, confirmed by ultrasound after 12 weeks of gestation.(From the day of embryo transfer until the confirmation of fetal viability at or after 12 weeks of gestation (typically up to 14 weeks of gestation).)