Hysterosalpingo-Foam Ultrasonography Combined With Power Doppler, Compared With Laparoscopy in Tubal Patency Assessment in Cases of Infertility

NCT05209542 | Completed DMC

• 1 other identifier: 63
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Women presenting with primary or secondary infertility and are undergoing investigation of tubal patency assessment will be subjected to:

• The examination is performed between days 5 and 10 of the menstrual cycle.
• Routine antibiotic prophylaxis using oral Azithromycin the day before and routine administration of NSAID rectal suppository one hour before the procedure
• Initially, real-time 2D +/- 3D vaginal ultrasound assessment of the pelvis
• The cervix is to be visualized with a Cusco speculum and to be cleaned with an antiseptic then A No. 5 pediatric Foley catheter will be introduced into the cervical os, using a tenaculum if necessary. The balloon is to be positioned in the lower uterine cavity and to be inflated with 2 ml of saline to prevent backflow of contrast medium through the cervix then the speculum will be removed and the vaginal transducer is going to be reintroduced in the longitudinal plane to confirm correct placement of the catheter.
• Initial 3-5 ml of foam contrast is to be introduced slowly into the endometrial cavity while the flow of contrast medium in each tube is evaluated using grayscale and power Doppler imaging
• Power Doppler is very helpful to confirm the direction of the flow as well as the acceleration during injection.
• Tubal patency and quality of visualization are classified according the following parameters:
• Flow over the whole length of the tube, fimbrial outflow or peritoneal spillage of contrast provided definite evidence of complete (i.e. proximal and distal) tubal patency.
• Paracornual flow only without visualization of fimbrial outflow or peritoneal spillage suggests at least proximal patency.
• Contrast filling of the endometrial cavity without cornual flow suggests possible tubal occlusion.
• Technical difficulty making tubal evaluation impossible
• Standard laparoscopic evaluation with the dye test (methylene blue staining) is to be performed 1 day after ultrasound tests with 1 day of hospitalization under general anesthesia.

Conditions

Infertility of Tubal Origin

Outcome Measures

Primary Outcomes (1)

• Tubal patency

  To evaluate the accuracy of Hysterosalpingo-Foam Sonography combined with Power Doppler in assessment of tubal patency in infertile women

  During the ultrasound

Study Arms (2)

Hysterosalpingo-Foam Ultrasonography

ACTIVE COMPARATOR

3-5 ml of foam contrast is to be introduced slowly into the endometrial cavity while the flow of contrast medium in each tube is evaluated using grayscale and power Doppler imaging

Procedure: Hysterosalpingo-Foam Ultrasonography; Procedure: Laparoscopy

laparoscopy

ACTIVE COMPARATOR

• Standard laparoscopic evaluation with the dye test (methylene blue staining) is to be performed 1 day after ultrasound tests with 1 day of hospitalization under general anesthesia

Procedure: Hysterosalpingo-Foam Ultrasonography; Procedure: Laparoscopy

Interventions

Hysterosalpingo-Foam Ultrasonography PROCEDURE

* Initial 3-5 ml of foam contrast is to be introduced slowly into the endometrial cavity while the flow of contrast medium in each tube is evaluated using grayscale and power Doppler imaging * Power Doppler is very helpful to confirm the direction of the flow as well as the acceleration during injection

Hysterosalpingo-Foam Ultrasonography; laparoscopy

Laparoscopy PROCEDURE

• Standard laparoscopic evaluation with the dye test (methylene blue staining) is to be performed 1 day after ultrasound tests with 1 day of hospitalization under general anesthesia

Hysterosalpingo-Foam Ultrasonography; laparoscopy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sexually active women in the reproductive age group between 20 and 40 years
• History of primary or secondary infertility ( either unexplained or suspected tubal factor by history taking )
• Tubal factor has not been investigated before or has been investigated with inconclusive results

You may not qualify if:

• Age less than 20 or above 40 years.
• Using contraception.
• Undiagnosed pregnancy.
• known allergy to lidocaine.
• active pelvic inflammatory disease or genital tract bleeding.
• Patent both tubes as assessed previously ( no need for exposure to further Investigation.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmed Mohamed Maged M ElGoly

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 26, 2022
• Study Start: February 9, 2018
• Primary Completion: February 17, 2020
• Study Completion: April 3, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

EG (1)