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临床试验/NCT02153814
NCT02153814已完成不适用

Pilot Study on the Effect of Endometrial Injury in Patients Undergoing in Vitro Fertilization (IVF)

Northwestern University2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
2
主要终点
Live Birth Rate

研究概览

简要总结

Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with sperm to make embryos, which are then placed in the woman's uterus using a small catheter, a procedure called "embryo transfer." Unfortunately, pregnancy rates from IVF are less than 50%. Recently, several studies have shown dramatically improved pregnancy rates by grazing the innermost lining of the uterus (the endometrium) with a small flexible catheter weeks prior to embryo transfer. These studies were all performed outside the United States (U.S.) in women with multiple failed IVF attempts and did not investigate the mechanisms by which endometrial injury works. This study will be the first to evaluate the effect of endometrial injury on IVF success in all women undergoing IVF, including first IVF cycles, frozen embryo transfers, and donor eggs.

详细描述

Nationally, the percentage of in vitro fertilization (IVF) cycles resulting in pregnancy is still less than 50%, even in optimal patients. While failed implantation may be due to embryo factors, in recent years much attention has been given to the role of endometrial receptivity at the time of embryo transfer. There is abundant evidence in the literature showing that, in women with repeated implantation failures despite having high quality embryos, endometrial injury performed either in the follicular phase of the IVF cycle or late in the cycle preceding the treatment cycle increases IVF success rates, often more than doubling the pregnancy rate.

The mechanism of improved pregnancy rates after endometrial injury is currently unknown. There is a paucity of studies in the current literature linking the biochemical and genetic changes induced by endometrial injury to pregnancy rates in patients undergoing IVF, as well as studies examining the effect of endometrial injury on ultrasound findings previously shown to predict IVF success, such as endometrial thickness, pattern, and volume, or markers of endometrial vascularity.

Additionally, no studies have been published examining whether or not IVF success rates can be improved in all-comers (not just women with repeated failures or abnormal appearing endometrium on ultrasound) by performing endometrial injury and there are currently no studies published on this topic with U.S. women in the study population. The proposed study would be the first to examine the effect of endometrial injury in U.S. women undergoing infertility treatment with IVF, regardless of prior treatment history, including women undergoing donor oocyte IVF cycles or frozen embryo transfer. It would also be the first to evaluate the biochemical changes induced by endometrial injury in the context of cycle outcome and live birth rate and to examine the effect on ultrasound parameters.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing IVF at the Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility
  • Age at time of egg retrieval 18-40 years, inclusive. Age at time of embryo transfer 18-45 years, inclusive.
  • All subjects must have given signed, informed consent prior to registration in study

排除标准

  • Patients with any current uterine pathology known to affect implantation, such as large hydrosalpinx, Asherman's syndrome, fibroids or polyps
  • Patients with active cervical or pelvic infection
  • Pregnant women
  • Patients with a serious bleeding diathesis (e.g. hemophilia)

结局指标

主要结局

Live Birth Rate

时间窗: 10 Months

次要结局

  • Implantation Rate(1 month)
  • Pregnancy Rate(2 months)
  • Endometrial tissue gene expression levels (CT values)(1 month)
  • Spontaneous Abortion Rate(4 months)
  • 3-D Ultrasound Results - endometrial volume in mm^3(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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