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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tubal Factor Infertility

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Islam Tarek Elkhateb

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university Kasr Alainy OBGYN hospital

Cairo, AlQuahira, Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IT28052022

Identifier Type: -

Identifier Source: org_study_id