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临床试验/NCT02197936
NCT02197936终止不适用

Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
1
主要终点
Frequency of peristaltic waves in Hz

研究概览

简要总结

Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain.

In this study, the uterine peristalsis of women with adenomyosis will be investigated. This condition is associated to heavy menstrual bleeding, menstrual pain and infertility.

详细描述

The peristalsis of the non-pregnant uterus is widely investigated and the role of correct peristalsis seems to be most important for correct sperm transport towards the fallopian tubes and implantation of the embryo. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and menorrhagia. The connection of impaired peristalsis and various clinical symptoms has been shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis, though the concept seems to be widely accepted.

It has also been repeatedly postulated that impaired peristalsis interferes with implantation of the embryo, yet Martinez-Conejero published a trial that showed a higher incidence of miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. This might either indicate that the postulated effect of peristalsis is wrong or, more likely, since this is a study in an IVF setting, that hormonal treatment with gonadotropin-releasing hormone (GnRH)-agonist could improve implantation.

It is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of uterine peristalsis are defined by Jiland already in 1996.

Findings resulting from the investigations in this study may help to determine the role and extent of impaired peristalsis in women with adenomyosis and possibly give new clues on potential treatments, as well as fill a gap in today's knowledge.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms.

排除标准

  • Postmenopausal women,
  • Pregnant women,
  • Gynaecological cancer,
  • GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy,
  • Endometriosis,
  • Uterine fibroids

结局指标

主要结局

Frequency of peristaltic waves in Hz

时间窗: five minutes

Frequencies of peristalsis in patients with and without adenomyosis will be compared.

Altitude of peristaltic waves in mm

时间窗: five minutes

The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.

次要结局

  • direction of uterine peristalsis: antegrade, retrograde(5 minutes, at time of ovulation)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tina Tellum

Medical Doctor

Oslo University Hospital

研究点 (1)

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Norwegian Adenomyosis Study III: Peristalsis | 临床试验