3D Ultrasound Uterine Characteristics of Women Undergoing IVF/ICSI Treatment
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
- 是
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
Sotirios Saravelos
Subspecialty Trainee in Reproductive Medicine
Imperial College Healthcare NHS Trust
