跳至主要内容
临床试验/NCT06847386
NCT06847386Enrolling By Invitation不适用

Research on the Effect of Hysteroscopic Metroplasty with Cold Scissors on Reproductive Outcome in Patients with Recurrent Implantation Failure

Shanghai First Maternity and Infant Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

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

No Intervention

Patients in this group receive embryo transfer without hysteroscopy

Hysteroscopy

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验