Hysteroscopic Evaluation of Fallopian Tubal Patency

Summary

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.

Conditions

• Infertility of Tubal Origin
• Infertility, Female
• Fallopian Tube Occlusion
• Uterus Abnormal

Interventions

DIAGNOSTIC_TEST

Hysteroscopic Fallopian tube assessment using the "Parryscope" technique

A small amount of air is introduced into the iv tubing by inverting the drip chamber to create air bubbles. When air enters the uterine cavity, a single large air bubble or stream of air bubbles traversing the ostia is considered indicative of tubal patency. At least 10 seconds of intracavitary evaluation is typically performed before air bubble entry to allow pressure equilibration if a hydrosalpinx is present \[10\]. At least 30 seconds of observation per ostia is performed if patency is not observed.

DIAGNOSTIC_TEST

Hysteroscopic Fallopian tube assessment using the "Tubal flow" technique

a positive "flow" is defined as the observation of saline directly traversing the ostia, endometrial structures floating toward the ostia, or air bubbles traversing the ostia.

Sponsors & Collaborators

• University of Mississippi Medical Center

  collaborator OTHER

• Medical University of Vienna

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-31

Primary Completion

2019-10-25

Completion

2019-10-25

Countries

• Austria

Study Locations