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

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:

1. 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.
2. Paracornual flow only without visualization of fimbrial outflow or peritoneal spillage suggests at least proximal patency.
3. Contrast filling of the endometrial cavity without cornual flow suggests possible tubal occlusion.
4. 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

Interventions

PROCEDURE

Hysterosalpingo-Foam Ultrasonography

* 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

PROCEDURE

Laparoscopy

• 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

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Ahmed Mohamed Maged M ElGoly · Cairo University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-09

Primary Completion

2020-02-17

Completion

2021-04-03

Countries

• Egypt

Study Locations