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临床试验/NCT03161119
NCT03161119Unknown不适用

Prospective Randomized Controlled Trial Comparing Two Different Embryo Transfer (ET) Catheters

Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2017年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
352
试验地点
2
主要终点
Prevalence of difficult transfers (Number of difficult transfers/ Total transfers)

研究概览

简要总结

Numerous published trials now document that the embryo transfer (ET) procedure has a huge impact on pregnancy and delivery rates after IVF (In Vitro Fertilization).

To compare the ease of use (defined as the rate of successful atraumatic insertion) of different types of embryo transfer (ET) catheters.

This prospective randomized unblinded controlled clinical trial is performed to determine if there is any difference in ease of use among 2 different catheters : Cook k-soft-5000, Cook K-JETS-551910-S.

Inclusion criteria: patients < / = 38 years of age, body mass index (BMI) between 18 and 28, at least one frozen-thawed blastocyst transferred.

Exclusion criteria: ICSI (Intracytoplasmic Sperm Injection)-TESE (Testicular Sperm Extraction) IVF cycles.

A number of 352 consecutive women undergoing embryo transfer will be selected for this prospective, randomized controlled trial. Two protocols for endometrial preparation will be used before frozen/thawed blastocyst transfer: the modified spontaneous protocol and the oral/transdermal preparation protocol. ET will be done with patient in lithotomy position, under ultrasound guidance. No anesthesia will be used for the procedure.

176 patients will be enrolled in this trial and randomized to enter one of the two catheter group.

详细描述

Introduction

Embryo transfer (ET) is the final and critical step in the long pathway of in vitro fertilization (IVF) treatment. Implantation is a complex process and, as yet, one not fully understood. Aside from the quality of the embryos replaced and the receptivity of the endometrium, the embryo transfer procedure itself might impact the implantation process.

The procedure has changed very little since the first descriptions. Numerous data suggest that difficult transfers should be avoided, as they are likely to reduce the chances of implantation and subsequent pregnancy rates.

It has been proposed on the basis of small studies that traumatic embryo transfer can induce uterine contractions capable of displacing the embryo or induce unwanted endometrial damage. The evidence is unclear, however, as whilst several studies support this concept, others do not.

Free hand embryo transfer with soft catheters under ultrasound guidance is considered the best option in transferring embryos. Many retrospective trials have reported higher Pregnancy Rates (PR) with soft catheters compared with hard catheters. However in technically difficult ET, where difficulties are met in negotiating the cervical os, the use of harder catheters is needed. The change from soft to hard catheters in these transfers, along with the difficulty of the transfer itself, may account for differences in pregnancy rate.

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
None

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • body mass index (BMI) between 18 and 28,
  • at least one frozen/thawed blastocyst

排除标准

  • ICSI-TESE cycles

研究组 & 干预措施

Catheter Cook K-Jets-551910-S

Experimental

Catheter Cook K-Jets-551910-S consists of an outer firm and an inner ultrasoft catheter. The outer guiding catheter (17 cm long) is slightly stiff, with a preshaped curve and a rounded bulb tip to help negotiate the cervical canal. It has a depth marker at 4 cm from the tip, which can be pulled back to a second marker at 5 cm. The inner catheter (23 cm long) is made of a soft material with a rounded bullet tip. In general, the inner catheter does not negotiate the cervical canal directly but rather is introduced into the uterine cavity through the outer catheter.

干预措施: Ultrasound guided embryotransfer with Cook K-Jets-551910-S (Device)

Catheter Cook k-soft-5000 (or K-J-SP-681710, K-J-SPPE-68171)

Active Comparator

This catheter system consists of an outer firm and inner soft catheter. The outer guiding catheter (15,4 cm long) is straight and made of flexible material. The inner catheter (23 cm long) is made of a very soft and flexible polyurethan. The inner catheter is introduced directly through the cervix.

干预措施: Ultrasound guided embryotransfer with Cook k-soft-5000 (or K-J-SP-681710 and K-J-SPPE-681710) (Device)

结局指标

主要结局

Prevalence of difficult transfers (Number of difficult transfers/ Total transfers)

时间窗: through study completion, 18 months

Difficult transfers are defined as 1. for Cook k-soft-5000 catheter: advancement of the outer sheath, multiple attempts, force, required manipulation, use of a stylet or tenaculum, dilatation; 2. for Cook K-JETS-551910-S catheter: required manipulation, multiple attempts, force, the use of a stylet or tenaculum, dilatation.

次要结局

  • Inter-operator variability in prevalence of difficult transfers with the 2 catheters(through study completion, 18 months)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (2)

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