Hysteroscopic Evaluation of Fallopian Tubal Patency Compared to Laparoscopic Chromopertubation: a Prospective, Randomized Study on the "Flow" and "Parryscope" Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fallopian tube patency using laparoscopic chromopertubation
研究概览
简要总结
Hysteroscopy is an important tool in the evaluation of sterility. Assessing tubal patency during hysteroscopy seems highly relevant, particularly when it allows for a low cost, fast, gentle, and accurate way of gathering information that may guide clinical care. Therefore, it is important to know which technique is the best. Thus, the primary aim of this study is to evaluate the reliability of (1.) the hysteroscopic visualization of a "tubal flow" and (2.) the "Parryscope technique" as compared to the gold standard, namely laparoscopic chromopertubation. In a prospective, randomized study, the following women are enrolled: (1.) The patient is subfertile, defined as being unable to become pregnant within a year despite unprotected sexual intercourse. It is also within the standard of care to be presumed subfertile if one has tried for six months and has known risk factors that would hinder conception, including but not limited to anovulation and endometriosis. (2.) A concurrent diagnostic hysteroscopy and laparoscopy with chromopertubation are performed at the Clinical Division of Gynecological Endocrinology and Reproductive Medicine at the Medical University of Vienna. Hysteroscopic evaluation of tubal patency (either by a positive "tubal flow" or a visible flow of air bubbles in the "Parryscope technique") and the result of the laparoscopic chromopertubation (tubal patency existing or not existing) will be the primary outcome parameters. A total 60 patients are enrolled (30 patients in the "flow assessment" group, 30 patients in the "Parryscope" group) and randomization is performed as block randomization in 4 blocks.
详细描述
Introduction and scientific background:
Hysteroscopy is an important tool in the evaluation of sterility. It allows direct visualization of the uterine cavity and enables the diagnosis of numerous pathologies. Hysteroscopy shows high reliability and is considered the gold standard for intrauterine evaluation.
When performing hysteroscopy, experts often assess the patency of the tubes via the visibility of flow of the hysteroscopic fluid going through the ostia of the tubes. In the recently published study "Assessment of tubal patency: A prospective comparison of diagnostic hysteroscopy and laparoscopic chromopertubation" - it has been demonstrated that visualizing contrasting substances disperse through the ostia is a significant and meaningful metric for tubal patency.
Pre- and posthysteroscopic vaginal sonography for the evaluation of the hysteroscopic fluid in the pouch of Douglas, selective hysteroscopic pertubation of the tubes and the visibility of air bubbles traversing through the Fallopian tube ostia after an air infusion into the uterine cavity have been reported to be reliable methods for hysteroscopic tubal patency assessment. Particularly the last one, also called the "Parryscope technique", named after its inventor, seems to be highly reliable, easy to conduct and clinically relevant. The "Parryscope technique" seems to perform even better than the technique evaluating the "tubal flow".
Assessing tubal patency during hysteroscopy is highly relevant, particularly when it allows for a low cost, fast, gentle, and accurate way of gathering information that may guide clinical care. Therefore, it is important to know which of the above-mentioned techniques is the best. This prospective randomized study aims to compare the hysteroscopic assessment of the tubes via "tubal flow" and the "Parryscope technique".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •The patient is subfertile, defined as being unable to become pregnant within a year despite unprotected sexual intercourse. It is also within the standard of care to be presumed subfertile if one has tried for six months and has known risk factors that would hinder conception, including but not limited to anovulation and endometriosis.
- •A concurrent diagnostic hysteroscopy and laparoscopy with chromopertubation are performed at the Clinical Division of Gynecological Endocrinology and Reproductive Medicine at the Medical University of Vienna.
- •The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
- •The patient is over 18 and under 45 years old.
排除标准
- •The patient had a tubectomy on one or both sides.
- •There is no "informed consent".
- •The patients has active vaginal infection or other conditions that would preclude hysteroscopy.
结局指标
主要结局
Fallopian tube patency using laparoscopic chromopertubation
时间窗: In the course of subsequent laparoscopy, i.e. 20-60 minutes after the diagnostic intervention
tubal patency as assessed by chromopertubation (information provided separately for each side)
次要结局
未报告次要终点
研究者
Johannes Ott
Assoc.Prof. Priv.Doz. Dr.
Medical University of Vienna
