Research on the Effect of Hysteroscopic Metroplasty with Cold Scissors on Reproductive Outcome in Patients with Recurrent Implantation Failure
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
In recent years with the continuous improvement of ART technology, it has brought new hope to infertile couples, however more than half of the patients still experience multiple transfer failures. Abnormalities in the structure of the uterine cavity are one of the main factors that lead to the failure of embryo implantation. Hysteroscopic metroplasty with cold scissors is an innovative technique of our team, in which micro-scissors are used in the procedure instead of the previous electric knife. Our previous study found that this technique has the effect of improving fertility outcomes in patients with T-shaped uterus.
Based on the previous study, this study is an open randomized controlled trial to include patients with more than 2 or more ART implantation failures. For the first time, cold knife hysteroscopic hysterectomy was used to treat patients with cryptic uterine stenosis in patients with repeated RIF implantation failures to assess the clinical efficacy of the technique and to investigate the effect of this technique on the pregnancy outcome of reimplantation of embryos in patients with repeated ART implantation failures. Meanwhile, this project is the first to study the diagnostic value of transvaginal 3D ultrasound/MRI for the assessment of uterine cavity status in patients with RIF, with a view to exploring the value of noninvasive imaging as an alternative to invasive hysteroscopy in the clinical management of RIF. The aim of the study is to provide a reference for early diagnosis and treatment of patients with repeated ART implantation failures, and to improve the pregnancy outcome of their reimplanted embryos.
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
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least twice previous implantation failures
- •Willing to receive further embryo transfer
排除标准
- •Sturctural intrauterine lesions
- •Severe adenomyosis
- •Premature ovarian failure
- •BMI > 35 kg/m^2
- •Severe systemic disease or maligant tumor
研究组 & 干预措施
Direct Embryo Transfer
Patients in this group receive embryo transfer without hysteroscopy
Hysteroscopy
Patients in this group receive hysteroscopic examination. If T-shaped uterus is diagnosed during the operation, hysteroscopic metroplasty will be performed.
干预措施: Hysterocopic metroplasty (Procedure)
结局指标
主要结局
Pregnancy rate
时间窗: From enrollment to the 18 months after the last embryo transfer
Proportion of patients whose blood β-hCG test is positive after embryo transfer
次要结局
- Fetal implantation rate(From enrollment to the 18 months after the last embryo transfer)
- Biochemical pregnancy rate(From enrollment to the 18 months after the last embryo transfer)
- Clinical pregnancy rate(From enrollment to the 18 months after the last embryo transfer)
- Miscarriage rate(From enrollment to the 18 months after the last embryo transfer)
