A Randomised Control Trial of Three-dimensional Versus Two-dimensional Ultrasound Guided Embryo Transfer in Women Undergoing Artificial Reproductive Technology Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 481
- 试验地点
- 1
- 主要终点
- Clinical pregnancy
研究概览
简要总结
Objectives: To assess whether embryo transfer guided by three-dimensional ultrasound (3DUS) produces a significantly higher clinical pregnancy rate than embryo transfer guided by two-dimensional ultrasound (2DUS).
Hypothesis: 3DUS guided embryo transfer will produce a significantly higher clinical pregnancy rate compared with 2DUS guided embryo transfer. Design and subjects: Prospective randomised control trial (RCT) at the Prince of Wales Hospital. Inclusion criteria include women undergoing embryo transfer in fresh and frozen cycles. Exclusion criteria include women aged >42 years and women whose endometrial cavity cannot be visualised adequately via US. Power calculations indicate that 232 patients per arm are required to demonstrate an increase of 12% in clinical pregnancy rates.
Study instruments: US examinations will be performed using a General Electric(GE) Voluson series US machine with a standard 3D transvaginal probe. For embryo transfer, the Cooks Guardia Access EchoTip catheter will be used.
Interventions: 3D versus 2DUS for guidance during embryo transfer. Main outcome measures: clinical pregnancy. Secondary outcome measures: implantation rate, multiple pregnancy, miscarriage, ectopic pregnancy and live birth rates.
Data analysis: Data processing and analysis will be performed using the Statistical Packages of Social Sciences for Windows (SPSS, Inc). Descriptive and comparative statistical methods will be used to analyse the primary outcomes. P-values of <0.05 will be considered significant.
Expected results: The study arm undergoing 3DUS guided embryo transfer are expected to have an improved clinical pregnancy rate compared with the control arm undergoing 2DUS guided embryo transfer.
详细描述
INTRODUCTION
The role and use of 2DUS in gynaecology is undisputed as it forms an integral part of diagnosing pathologies of the uterus, tubes and ovaries. In reproductive medicine, it is of particular significance as it is additionally the most widespread tool available to monitor endometrial thickness, follicular status and growth, allow guided retrieval of oocytes from the ovary and also guided transfer of fertilised embryos into the uterus [1]. These are undoubtedly some of the most critical procedures/steps of ART.
The development of 3DUS has brought somewhat of a breakthrough in the field as now 3D volumes of images can be acquired and analysed live or retrospectively. From a practical perspective, the scanning procedure does not differ from the routine 2D US and the acquisition of a 3D volume requires only a few seconds. Analysis of these volumes allows reconstruction of planes which are not always possible with 2DUS (such as the 3D coronal plane of the uterus). As a result, 3DUS is now considered to be the most accurate non-invasive modality to diagnose uterine anomalies [2, 3]. Furthermore, 3DUS allows accurate volume calculations of structures such as the endometrium and follicles. These new possibilities, coupled with advanced software now also allows for automated measurements of these variables, which may improve accuracy, reduce interobserver variability and increase efficiency of an ART unit [4].
Several publications now in the literature support that 3DUS may play a major role in ART in the future [5-8]. Areas which 3D US may provide additional information are:
- Assessment of ovarian blood flow, follicular volume and growth [9]
- Assessment of endometrial and subendometrial blood flow and volume [10, 11]
- Assessment of precise catheter placement during embryo transfers [12] The latter is perhaps the area which has been the least investigated so far, despite embryo transfer being arguably the step of highest importance throughout the entire ART process. Two preliminary studies have shown that 3DUS guided embryo transfer significantly improves catheter placement compared with 2DUS [13] and can allow for correction of up to 20% of mal-positioned catheters where 2DUS alone has been used [14]. The largest series to date, has demonstrated that by use of 3DUS, the placement of embryos can be performed in the so called maximum implantation potential point, which is where the trajectories of the fallopian tubes meet in the centre of the uterine cavity, where the endometrial thickness and blood flow is thought to be greatest [12]. However, to our knowledge, there has been no randomised controlled trial (RCT) in the literature to systematically test 3DUS versus 2DUS guided embryo transfer with respect to pregnancy outcomes. If 3DUS guided embryo transfer is confirmed to produce a higher pregnancy rate than 2DUS guided embryo transfer, it will have significant impact on the daily clinical practice of ART units worldwide.
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
- Single (Participant)
入排标准
- 年龄范围
- 24 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing embryo transfer 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
研究组 & 干预措施
Two-dimensional ultrasound
Two-dimensional ultrasound guided embryo transfer
干预措施: Two-dimensional ultrasound (Device)
Three-dimensional ultrasound
Three-dimensional ultrasound guided embryo transfer
干预措施: Three-dimensional ultrasound (Device)
结局指标
主要结局
Clinical pregnancy
时间窗: 12 months
Clinical pregnancy rate following ART treatment
次要结局
- Implantation(12 months)
- Multiple pregnancy(12 months)
- Miscarriage(12 months)
- Ectopic pregnancy(12 months)
研究者
Sotirios Saravelos
Dr
Chinese University of Hong Kong
