跳至主要内容
临床试验/NCT04363879
NCT04363879已完成不适用

Comparing Two Types of Endometrial Activation Prior to Embryo Transfer: A Pilot Study

Wake Forest University Health Sciences0 个研究点目标入组 195 人开始时间: 2014年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
195
主要终点
Number of Participants With Live Births Per Transfers Performed

研究概览

简要总结

To determine if two types of endometrial activation (Pipelle curette or Shepard catheter) prior to embryo transfer result in similar live birth rates. Also to determine if patients experience similar pain from both types of endometrial activation.

详细描述

Assisted reproductive technologies (ART), including in vitro fertilization (IVF), are methods used to treat infertility, which affects approximately 10% reproductive aged women. Physicians at the Women's Institute perform over 300 embryo transfer procedures every year. Despite advances and improvements in ART over the past three decades, clinical pregnancy rate and live birth rate remain 30-40% and 20-30%. Implantation is essential for successful ART and IVF procedures, and many interventions have been studied to possibly improve implantation rates and thus pregnancy and live birth rates.

Endometrial activation is one such intervention, sometimes referred to as endometrial "activation" or "scratch," and it is defined as "intentional endometrial injury, such as endometrial biopsy or curettage, in women undergoing ART".

A previous study found that implantation rates, clinical pregnancy rates, and live birth rates were more than twofold higher in women who underwent endometrial biopsy in the cycle before subsequent IVF treatment. Another study which examines endometrial activation prior to IVF similarly has concluded that endometrial activation prior to the embryo transfer cycle significantly improves clinical pregnancy rates and live birth rates in women undergoing ART. Although the type of endometrial procedure is not specified, the timing activation was found be most effective when performed in the cycle prior to the embryo transfer.

The mechanism of increase endometrial receptivity is still unknown; however three proposed hypothesis exist. The first hypothesis proposes that local activation of the endometrium induces endometrial decidualization which increases the probability of embryo implantation. The second hypothesis is that endometrial healing following endometrial activation increases secreted cytokines, interleukins, growth factors, macrophages, and dendritic cells which are beneficial to embryo implantation. The final hypothesis suggests that endometrial maturation is abnormally advanced during ovarian stimulation, so endometrial activation may lead to better synchronicity between the endometrium and the embryo..

Endometrial activation has been found to have clear benefit in pregnancy and live birth rates in a previous study, however no uniform technique has been determined. The objective of this study is to compare two types of endometrial disruption - a vigorous endometrial biopsy with a Pipelle curette and a four quadrant endometrial "scratch" using a Shepard insemination catheter - to determine if the live birth rates are equivalent for the two methods. The investigators also will compare pain with the two types of endometrial activation. By comparing two distinct types of endometrial activation, the goal is to determine which method is both effective and tolerable to patients.

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 55 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •All patients undergoing embryo transfer who are in the cycle prior to their embryo transfer

排除标准

  • •Patients not undergoing embryo transfer
  • •Known pregnancy
  • •Active pelvic infection
  • •Known endometrial hyperplasia or cancer
  • •Inability to tolerate endometrial catheter placement
  • •Severe cervical stenosis
  • •Patients who will receive operative hysteroscopy in the cycle prior to embryo transfer

研究组 & 干预措施

Endometrial scratch with Shepard catheter

Experimental

For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.

干预措施: Endometrial scratch with Shepard catheter (Procedure)

Endometrial scratch with Pipelle curette

Active Comparator

For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.

干预措施: Endometrial scratch with Pipelle curette (Procedure)

结局指标

主要结局

Number of Participants With Live Births Per Transfers Performed

时间窗: Collected up to 1 year after the last embryo transfer

Number (count) of births per number of subjects undergoing embryo transfer

次要结局

  • Pain Quantifcation After Endometrial Scratch(Immediately following endometrial scratch)
  • Number (Count) of Positive Pregnancy Tests Per Number of Subjects Undergoing Embryo Transfer(Collected up to 1 year after the last embryo transfer)
  • Number (Count) of Pregnancies Per Number of Patients Undergoing Embryo Transfer(Collected up to 1 year after the last embryo transfer)

研究者

申办方类型
Other
责任方
Sponsor

相似试验