Clincosm LogoSign in Get a demo

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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05419921
Collaborator
Shaimaa Mostafa (Other), Yasmin Zakaria (Other), Ibrahim Fawzy (Other), Mona Aboulghar (Other), Mona Fouad (Other)
105
Enrollment
1
Location
27
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)

Study Design

Study Type:
Observational
Anticipated Enrollment :
105 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. [July 2022- June 2024]

Secondary Outcome Measures

  1. Diagnostic accuracy of adding power doppler to the HyLiFoSy [July 2022- June 2024]

    Same outcome (tubal patency) will be assessed by US after adding color doppler mode. Accuracy will be represented using the same measures; sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.

  2. Evaluate the procedure associated pain [July 2022- June 2024]

    Pain will be assessed during the procedure (after insertion of Foley's catheter, during injection of lidocaine-made gel foam) using the verbal rating scale (VRS). Interpretation will be like: no pain, mild pain, moderate pain, severe pain.

  3. Evaluate the procedure duration [July 2022- June 2024]

    Duration is calculated in minutes, from the introduction of Cusco speculum to the exit of Foley's catheter

  4. Percentage of failed or inconclusive attempts and possible reasons for that [July 2022- June 2024]

  5. Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation [July 2022- June 2024]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:

  1. Age group (18-40)

  2. Informed signed Written consent.

  3. Scheduled for LDT as a part of their infertility management

  4. Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.

  5. 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:

  1. LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology

  2. Lack of good-quality HSG images.

  3. Withdrawal of consent.

  4. Using contraception

  5. Women outside reproductive age

  6. Known allergy to lidocaine

  7. Active pelvic inflammatory disease

  8. Undiagnosed genital tract bleeding.

  9. Evident tubal pathology (such as hydrosalpinx) or pregnancy diagnosed by transvaginal ultrasound (TV-US) prior to performing HyLiFoSy-PD

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Kasr Alainy OBGYN hospital Cairo AlQuahira Egypt

Sponsors and Collaborators

  • Cairo University
  • Shaimaa Mostafa
  • Yasmin Zakaria
  • Ibrahim Fawzy
  • Mona Aboulghar
  • Mona Fouad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Islam Tarek Elkhateb, Assistant lecturer, NewGiza University
ClinicalTrials.gov Identifier:
NCT05419921
Other Study ID Numbers:
  • IT28052022
First Posted:
Jun 15, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Lidocaine

Study Results

No Results Posted as of Jun 15, 2022