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

Tubal Factor Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419921
• Other study ID #: IT28052022
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2022
• Source: Cairo University
• Contact: Islam T. Elkhateb, M.Sc.
• Phone: 00201021656385
• Email: islamtarekhamed[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Infertility
• Tubal Factor Infertility

Intervention

Diagnostic Test:
• Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)
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.

Locations

Country	Name	City	State
Egypt	Cairo university Kasr Alainy OBGYN hospital	Cairo	AlQuahira

Sponsors (6)

Lead Sponsor	Collaborator
Cairo University	Ibrahim Fawzy, Mona Aboulghar, Mona Fouad, Shaimaa Mostafa, Yasmin Zakaria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the procedure associated pain	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.	July 2022- June 2024
Secondary	Evaluate the procedure duration	Duration is calculated in minutes, from the introduction of Cusco speculum to the exit of Foley's catheter	July 2022- June 2024
Secondary	Percentage of failed or inconclusive attempts and possible reasons for that		July 2022- June 2024
Secondary	Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation		July 2022- June 2024