NCT05419921TerminatedNot Applicable
Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Cairo University
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
Study Overview
Brief Summary
This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age group (18-40)
- •Informed signed Written consent.
- •Scheduled for LDT as a part of their infertility management
- •Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.
- •No incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Exclusion Criteria
- •LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology
- •Lack of good-quality HSG images.
- •Withdrawal of consent.
- •Using contraception
- •Women outside reproductive age
- •Known allergy to lidocaine
- •Active pelvic inflammatory disease
- •Undiagnosed genital tract bleeding.
- •Evident tubal pathology (such as hydrosalpinx) or pregnancy diagnosed by transvaginal ultrasound (TV-US) prior to performing HyLiFoSy-PD 10- Incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Outcomes
Primary Outcomes
Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
Time Frame: July 2022- June 2024
Secondary Outcomes
- Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation(July 2022- June 2024)
- Evaluate the procedure associated pain(July 2022- June 2024)
- Evaluate the procedure duration(July 2022- June 2024)
- Percentage of failed or inconclusive attempts and possible reasons for that(July 2022- June 2024)
Investigators
Islam Tarek Elkhateb
Assistant lecturer
NewGiza University
Study Sites (1)
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