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

NCT ID: NCT05537805

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2024-03-01

Brief Summary

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

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.

Conditions

Fallopian Obstruction Tube

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

proximal tubal occlusion

Infertile patients that were referred to our unit for uni or bilateral proximal tubal occlusion demonstrated by HyFoSy or hysterosalpingography.

Group Type: EXPERIMENTAL

Ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yaakov Melcer

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Kohi MP. Interventional Radiologist's Approach to Fallopian Tube Recanalization. Tech Vasc Interv Radiol. 2021 Mar;24(1):100736. doi: 10.1016/j.tvir.2021.100736. Epub 2021 Apr 16.

Reference Type: BACKGROUND

PMID: 34147190 (View on PubMed)

Wang JW, Rustia GM, Wood-Molo M, Tasse J, Tabriz D, Turba UC, Arslan B, Madassery S. Conception rates after fluoroscopy-guided fallopian tubal cannulation: an alternative to in vitro fertilization for patients with tubal occlusion. Ther Adv Reprod Health. 2020 Oct 8;14:2633494120954248. doi: 10.1177/2633494120954248. eCollection 2020 Jan-Dec.

Reference Type: BACKGROUND

PMID: 33103116 (View on PubMed)

Pyra K, Szmygin M, Dymara-Konopka W, Zych A, Sojka M, Jargiello T, Leszczynska-Gorzelak B. The pregnancy rate of infertile patients with proximal tubal obstruction 12 months following selective salpingography and tubal catheterization. Eur J Obstet Gynecol Reprod Biol. 2020 Nov;254:164-169. doi: 10.1016/j.ejogrb.2020.08.008. Epub 2020 Sep 16.

Reference Type: BACKGROUND

PMID: 32979628 (View on PubMed)

De Silva PM, Chu JJ, Gallos ID, Vidyasagar AT, Robinson L, Coomarasamy A. Fallopian tube catheterization in the treatment of proximal tubal obstruction: a systematic review and meta-analysis. Hum Reprod. 2017 Apr 1;32(4):836-852. doi: 10.1093/humrep/dex022.

Reference Type: BACKGROUND

PMID: 28184438 (View on PubMed)

Other Identifiers

0275-21-ASF

Identifier Type: -

Identifier Source: org_study_id