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

NCT05419921 | Terminated

• 1 other identifier: IT28052022
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Tubal Factor Infertility

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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

• Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation

  July 2022- June 2024

Interventions

Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD) DIAGNOSTIC_TEST

Women in the reproductive age group between 18- and 40-years old presenting with primary or secondary infertility who underwent HSG in the previous 5 years as a part of their infertility work-up with availability of good-quality HSG images, \& did not get pregnant in this period, and gave no history of incidences that might affect their tubes, such as : abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion. Women fitting these inclusion criteria and scheduled for LDT as part of their infertility work up will be considered. HyLiFoSy-PD will be carried out few days before the already scheduled LDT.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women in the reproductive age group between 18- and 40-years old presenting with primary or secondary infertility who underwent HSG in the previous 5 years as a part of their infertility work-up with availability of good-quality HSG images, \& did not get pregnant in this period, and gave no history of incidences that might affect their tubes, such as : abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion. Women fitting these inclusion criteria and scheduled for LDT as part of their infertility work up will be considered. HyLiFoSy-PD will be carried out few days before the already scheduled LDT.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university Kasr Alainy OBGYN hospital

Cairo, AlQuahira, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 15, 2022
• Study Start: February 1, 2018
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)