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临床试验/NCT03062098
NCT03062098撤回不适用

Optimizing the Technique of Embryo Transfer in IVF Using Better Imaging Guidance

Rambam Health Care Campus1 个研究点 分布在 1 个国家开始时间: 2017年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Imaging quality

研究概览

简要总结

This trial seeks to improve ultrasound imaging during embryo transfer in IVF by using a small, high resolution ultrasound probe used routinely for cardiac imaging in children.

详细描述

Since the first pregnancy using IVF was achieved nearly 40 years ago, many aspects of this procedure have undergone significant progress. In contrast, the technique of embryo transfer (ET) has remained relatively unchanged. A simple yet critical element in the final step of IVF, ET has received little attention. In general, the procedure starts by placing a speculum in the vagina to visualize the cervix, which is cleansed with saline solution or culture media. A transfer catheter is loaded with the embryos is inserted through the cervical canal and advanced into the uterine cavity where the embryos are deposited.

The catheter is then withdrawn and handed to the embryologist, who inspects it for retained embryos. Ultrasound (US) guidance is used to facilitate atraumatic insertion of the catheter, as well as ensure correct location in the uterine cavity.

The available evidence suggests that there is a benefit of using US guidance during ET (Teixeira et al, Ultrasound Obstet Gynecol. 201;45:139-48, Abou-Setta et al, Fertil Steril. 2007;88:333-41).

High quality US imaging is difficult to achieve if the distance from the abdominal wall to the uterus is big (thick abdominal wall, retro-verted uterus), or if the bladder is not full enough.

High resolution US imaging dictates short distance between the US transducer and the organ of interest (in our case cervical canal and endometrium). Previous effort in that direction was done using a vaginal US probe. However, this instrumentation makes the ET technique cumbersome and difficult to perform. We hypothesize that a significant advantage in imaging quality can be achieved by placing a flat or concave high frequency US transducer in the posterior fornix as an extension of the posterior speculum blade.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •IVF patients before embryo transfer. -

排除标准

  • •IVF patients not willing to participate

研究组 & 干预措施

IVF patients

Experimental

IVF patients before embryo transfer. Before performing embryo transfer in the routine manner, ten patients will be asked to participate in the study. After signing informed consent, participants will undergo the experimental procedure: Speculum will be placed to visualize the cervix. The thin ultrasound probe will be places posterior to the cervix. While viewing the image on the ultrasound screen, the probe will be moved manually to obtain the best imaging of the cervical canal. An empty embryo transfer catheter will be introduced to the cervical canal and will be advanced under ultrasound imaging up to the internal os. The catheter will be withdrawn, and routine embryo transfer will follow.

干预措施: ultrasound imaging (Device)

结局指标

主要结局

Imaging quality

时间窗: About 1 minute

Characterization of exact ultrasound image planes while placing an ultrasound probe within the posterior fornix, for anatomical optimization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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