Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05209542 |
| Other study ID # |
63 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2018 |
| Est. completion date |
April 3, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
