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临床试验/NCT02549235
NCT02549235Unknown不适用

3D Ultrasound Uterine Characteristics of Women Undergoing IVF/ICSI Treatment

Imperial College London1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Clinical pregnancy

研究概览

简要总结

The purpose of this trial is to evaluate the morphological characteristics of the uterus with three-dimensional ultrasound (3DUS) at the time of IVF/ICSI treatment and correlate it to clinical outcomes. The uterus will be assessed in the 3D coronal plane and measurements will be performed to assess whether they correlate with clinical pregnancy rate, miscarriage rate and live birth rate.

详细描述

INTRODUCTION

There has been a lot of increased interest in the recent years in the prevalence and diagnosis of congenital uterine anomalies (Chan et al 2011; Saravelos et al 2008). This has been further intensified by the introduction of several new classifications for these malformations, including the most recent ESHRE-ESGE classification (Grimbizis et al, 2013).

Most of the clinical interest, and what affects daily clinical practice is the diagnosis and treatment of the septate uterus, which is the commonest anomaly amenable to treatment (Homer and Li, 2000). Since the new ESHRE-ESGE classification, which has introduced a new objective method for diagnosis of this anomaly, by measuring the percentage of fundal indentation and considering to be a septate uterus when it is >50%.

To our knowledge there have been no prospective studies as yet assessing women undergoing ART in order to demonstrate whether indeed the 3D US morphological characteristics (including the percentage of fundal indentation) are correlated to either clinical pregnancy or clinical miscarriage. Indeed, this is of upmost importance, as for example the decision to operate on a so-called septate uterus should be based on whether it has a true impact on clinical outcomes. This is all the more most topical in the present era of IVF/ICSI, and the new classifications for uterine anomalies, as certain authors have criticized the new ESHRE-ESGE classification as significantly over-diagnosing the septate uterus which risks causing unnecessary interventions (Ludwin et al, 2015). Meanwhile other 3D US morphological characteristics such as characterisation of the subendometrial layers/junctional zone and Cesarean scan niches my also prove to be correlated with clinical outcomes.

AIMS Aim: To determine whether and to what extent different 3D US morphological characteristics of the uterus impact the clinical outcomes of women undergoing IVF/ICSI.

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 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing IVF/ICSI in either fresh or frozen cycles.
  • Women whose endometrial cavity can be visualised adequately via US

排除标准

  • Women aged >42 years
  • Women whose endometrial cavity cannot be visualised adequately via US, such as large fibroids, adenomyosis, BMI>35, significant uterine retroflexion/retroversion
  • Previous uterine surgery (e.g. septum resection, adhesiolysis)

结局指标

主要结局

Clinical pregnancy

时间窗: 28 days from embryo transfer

Clinical pregnancy

次要结局

  • Ectopic pregnancy(28 days from embryo transfer)
  • Ongoing pregnancy(12 weeks from embryo transfer)
  • Clinical miscarriage(until 12 weeks of pregnancy)

研究者

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

Sotirios Saravelos

Subspecialty Trainee in Reproductive Medicine

Imperial College Healthcare NHS Trust

研究点 (1)

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