Ultrasound Guided Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography (HyFoSy) (HyFoSy)

September 8, 2022 updated by: Yaakov Melcer, Assaf-Harofeh Medical Center

Ultrasound Guided Transcervical Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography in the Treatment of Proximal Tubal Obstruction

Investigate a novel ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Tubal catheterization is usually reserved for infertility treatment in selected cases of proximal tubal occlusion. As the incidence of this condition is limited to approximately 10-20% of women with mechanical infertility, the hitherto published data concerning the best therapeutic approach for these patients is scarce.

Hysterolaparoscopy with dye instillation is considered the gold standard for comprehensive evaluation of the female reproductive organs. Moreover, while the gold standard for evaluation of the uterine cavity is diagnostic hysteroscopy and hydrosonography, tubal patency may be validated by either hystrosalpingography, or ultrasonic evaluation using Echovist-200. However, interpretation of the passage of contrast medium into the proximal portion of the tube remains somewhat uncertain.

Since hysterolaparoscopy with dye instillation, is an expensive and an invasive procedure, with potentially life-threatening risks, the search for a safer and less invasive techniques is still ongoing. In 2012, Hysterosalpingo-Foam Sonography was introduced as a new technique for assessing fallopian tube patency. During the exam, the passage of a hyper-echogenic foam composed of a mixture of gel and purified water can be visualized as it progresses from the uterine cavity through the fallopian tubes into the peritoneal cavity. Hysterosalpingo-foam sonography is a promising alternative for laparoscopy and hysterosalpingography with regard to accuracy and effectiveness and has been suggested as a first step test of tubal assessment since it is relatively safe, non (embryo-) toxic and non-invasive.

In the present report the investigators aim to perform an ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonographyin the treatment of proximal tubal obstruction. This "one stop - shop" procedure combines uterine cavity investigation and assessment of tubal patency, with the concomitant advantage of therapeutic tubal re-canalization.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

• uni or/and bilateral proximal tubal occlusion.

Exclusion Criteria:

  • ongoing pregnancy
  • positive Human Chorionic Gonadotropin test
  • active pelvic inflammatory disease
  • vaginal bleeding
  • presence of distal tubal occlusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proximal tubal occlusion
Infertile patients that were referred to our unit for uni or bilateral proximal tubal occlusion demonstrated by HyFoSy or hysterosalpingography.
Procedure: Ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction
The intervention included the usage of the modified cornual cannulation set (COOK) which was inserted through cervical canal to uterine cavity, followed by fallopian tube irrigation with contrast foam (Ex-EM) during hysterosalpingo-foam sonography under ultrasonographic imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with proximal tubal obstruction who referred for tubal catheterization in order to achieve fallopian tube recanalization (patency).
Time Frame: 18 month
Tubal patency after tubal catheterization procedure demonstrated by hysterosalpingo-foam sonography.
18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

September 4, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 0275-21-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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