Hysterosalpingo-Foam Ultrasonography Combined With Power Doppler, Compared With Laparoscopy in Tubal Patency Assessment in Cases of Infertility
Condition: Infertility of Tubal Origin
MeSH terms: Infertility
Study type: Interventional

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.
    

Detailed description: 
      Women in the reproductive age group between 20 and 40 years old presenting with primary or
      secondary infertility ( either unexplained or suspected tubal factor by history taking ) and
      are undergoing investigation of tubal patency assessment

      Each patient in this study will be subjected to:

        -  The examination is performed between days 5 and 10 of the menstrual cycle, the patient
           in gynecological position, preferably with the aid of one assistant.

        -  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 pelvic organs is to
           be performed using Samsung Elite with endovaginal probe of frequency 6-12 MHz

        -  The cervix is to be visualized with a Cussco 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.

        -  The foam contrast agent is created by combining 3-4mL of 2% lidocaine gel 12-13mL of
           saline and 3mL air.

        -  The assistant creates the foam immediately before application, moving the mixture
           between two connected 20-mL syringes, until a whitish suspension is obtained
           (approximately 10-20 times).

        -  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.

        -  Acquisition without Doppler usually takes less than 5 s, while acquisition with power
           Doppler is longer(approximately 10 s)

        -  After dataset acquisition, Images will be stored as 2D still images, 2D clips +/- 3D
           volumes. the patient is to be discharged and final diagnosis is made based on the
           real-time observations and, if available, offline analyses of acquired datasets.

        -  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 e.g. absent filling of the
                endometrial cavity due to backflow of contrast, inability to introduce the catheter
                into the cervical os or maintain the catheter in the correct position preventing
                instillation of contrast into the endometrial cavity.

        -  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.

        -  The raters are to be blinded to the results of the ultrasound examination until
           endoscopic diagnosis is to be performed

        -  Comparison between the results of the above mentioned techniques will be done and
           statistical analysis of the results will be carried out
    

Intervention name(s): Hysterosalpingo-Foam Ultrasonography; Laparoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; • 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
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic