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临床试验/NCT03860636
NCT03860636已完成不适用

The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction

University of Nottingham1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2018年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
1
主要终点
Number of clinical pregnancies

研究概览

简要总结

To measure the accuracy of different ultrasound endometrial patterns to predict successful embryo implantation during assisted conception; in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).

详细描述

Ultrasound appearance of the endometrium may predict successful implantation in assisted conception, but studies have yielded conflicting results.

The explanation may be different timing of, and classification systems for, the scan, different treatment protocols, and different definitions of success. Also scan quality has improved over time.

This is a prospective study looking at the endometrial pattern as a predictor of IVF/ICSI outcome, adjusting for embryo quality, ease of transfer, and fresh or frozen cycles. The study will focus on good quality single embryo transfer at the blastocyst stage. Other endometrial ultrasound parameters such as thickness, volume and Doppler will also be measured. Reliability studies will also be conducted to assess and account for inter- and intra-observer variation.

200 women will be recruited. They will include approximately 100 undergoing fresh and 100 undergoing frozen embryo transfer. There will be no change to routine clinical care. A single operator will analyse all ultrasound images to reduce inter-observer variation. When there is uncertainty about the pattern the chief investigator will be consulted to reach an agreement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female undergoing in vitro fertilisation or intracytoplasmic sperm injection (IVF/ICSI)
  • Own or donated eggs
  • Informed consent

排除标准

  • Known pathology affecting the endometrial cavity (polyp, submucosal fibroid)
  • Septate uterus or more complex uterine abnormality.

结局指标

主要结局

Number of clinical pregnancies

时间窗: Within 12 weeks after embryo transfer (usually scan performed at 6-7 weeks gestation)

Intrauterine pregnancy with fetal heart detected on ultrasound arising from the treatment cycle

次要结局

  • Number of biochemical pregnancies(Within 6 weeks after embryo tranfer)
  • Number of miscarriages(Within 12 weeks after embryo transfer)
  • Number of live birth(Within one year after embryo transfer)
  • Number of ectopic pregnancies(Within 10 weeks after embryo transfer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nick Raine Fenning

Chief Investigator

University of Nottingham

研究点 (1)

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