Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT05537805
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2022-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography (HyFoSy)
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Study Overview
Official Title:
Ultrasound Guided Transcervical Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography in the Treatment of Proximal Tubal Obstruction
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HyFoSy
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: