Hysteroscopic Evaluation of Fallopian Tubal Patency

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Study aims: 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. Study hypotheses: Null hypothesis: The hysteroscopically visualizable tubal flow and the Parryscope technique are similarly reliable in the evaluation of tubal patency. Alternative hypothesis: The hysteroscopically visualizable tubal flow shows a lower sensitivity and specificity than the Parryscope technique for the evaluation of tubal patency. Study design: Prospective, randomized study. Recruitment: Women will be invited to participate by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna using the above mentioned criteria in the course of their admission to the ward one day before surgery. Potential participants are informed about the procedure, clinical relevance and the balance of risk and benefits incurred through study participation. Patients willing to participate will express this through written affirmation (a consent form). Additional considerations: Since in the flow-group air bubbles might develop spontaneously and, thus, should be assessed, conducting the Parryscope-technique is only possible after the evaluation of the tubal flow. Reactive tubal spasms could occur especially during a prolonged hysteroscopy. This is why in one particular patient only one technique should be performed. Sample size calculation: The calculation is based upon the following considerations: Direct comparison of the two groups is not possible. Hence, separate evaluation of the two methods will be performed. Evaluating both methods in one particular patient in the course of a single intervention is impossible without a mutual interference (see: Additional considerations above). The flow effect is considered the less reliable method and thus, the sample size was aligned to this method. An odds ratio of approximately 10, an alpha of 5%, a power of 80%, a general disease likelihood of 39% and a sensitivity of 66% for occluded tubes result in a total amount of 59 tubes and, accordingly, 30 patients. Thus, the group for the Parryscope-technique should also contain 59 tubes (= 30 patients). The randomization of the total 60 patients is performed as block randomization in 4 blocks via the software R. Statistical analysis: Numerical data will be reported as mean and standard deviations, nominal variables as number and frequency. The McNemar Test will be used for the calculation of the reliability of the hysteroscopic assessment of the tubes. The sensitivity, specificity, positive and negative predictive values will be provided including the according 95% confidence intervals (95% CI) for both study groups (evaluated technique versus gold standard laparoscopic chromopertubation). Whether the according odds ratio is over 10 will be evaluated by the use of a binary logistic regression model. Statistical analyses were performed with the software R. Differences were considered significant if p<0.05. Data quality evaluation: Extreme values will be double-checked. In addition, a random checks by two independent investigators to ensure the accuracy of the data will be conducted.

Official Title
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Hysteroscopic Evaluation of Fallopian Tubal Patency Compared to Laparoscopic Chromopertubation: a Prospective, Randomized Study on the Flow and Parryscope Techniques

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

Intervention / Treatment
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* Diagnostic Test: Hysteroscopic Fallopian tube assessment using the Parryscope technique
* Diagnostic Test: Hysteroscopic Fallopian tube assessment using the Tubal flow technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parryscope-group<br>In these patients, Fallopian tube patency is assessed 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 Parryscope technique<br>* 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.<br>|
| Active Comparator: Tubal flow-group<br>In these patients, Fallopian tube patency is assessed using the 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. | Diagnostic Test: Hysteroscopic Fallopian tube assessment using the Tubal flow technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fallopian tube patency using laparoscopic chromopertubation | tubal patency as assessed by chromopertubation (information provided separately for each side) | In the course of subsequent laparoscopy, i.e. 20-60 minutes after the diagnostic intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysteroscopy, Parryscope, chromopertubation