Sonohysterography , 3D Ultrasonography and Hysteroscopy in Assessment of Uterine Factor in Cases of Female Infertility
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|ClinicalTrials.gov Identifier: NCT02399501|
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : March 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: hysteroscopy Device: two dimensional ultrasound Device: saline sonohysterography Device: three dimensional ultrasound||Not Applicable|
All patients will be examined by 2D transvaginal ultrasound using a 6.5 MHz probe (Sonoace 5000, Medison Co. Ltd, korea). Examination is performed after emptying of the bladder in dorsal lithotomy position.
Three dimensional ultrasound will be performed using Medison, Voulson 530 D-MT ultrasound machine (Medison Co. Ltd, Korea). The uterus is visualized in the longitudinal plane, the ultrasound probe is kept steady and the patient is asked to lie still on the examination bed.
Sonohysterography will be done after introduction of the catheter into the cervix, a twenty milliliter syringe which is prefilled with the distending media (saline) is then fitted to the catheter. The speculum is removed and endovaginal probe is introduced in the posterior vaginal fornix. The uterus is then visualized in the longitudinal plane to demonstrate the endometrial cavity and the catheter. Once this is possible, sterile saline is slowly injected through the catheter into the uterine cavity; up to ten milliliter of saline is usually enough for the procedure.
Hysteroscopy will be done under general anesthesia. The hysteroscopy is rigid continuous flow diagnostic hysteroscopy . It has a 30º panoramic optic which is 4 mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sonohysterography and 3D Ultrasonography Versus Diagnostic Hysteroscopy in Assessment of Uterine Factor in Cases of Female Infertility|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: uterine lesion ultrasound, hysteroscopy
evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
Hysteroscopy is done under general anesthesia. The hysteroscopy used is rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl Storz, Germany). It has a 30º panoramic optic which is 4 mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.
Device: two dimensional ultrasound
Examination is performed after emptying of the bladder in dorsal lithotomy position .The probe is introduced into the posterior fornix of the vagina, then the following structures are examined, the uterus for site, size and mobility, the myometrium for fibroids and adenomyosis, the endometrium for uniformity, polyps, submucous fibroids and intrauterine adhesions, the cervix for nabothian follicles and polyps, the adenexa and ovaries for site, size, mobility, follicles, cysts and corpus luteum
Other Name: (Sonoace 5000)
Device: saline sonohysterography
sterile speculum is introduced and the vagina and cervix is cleaned with povidone iodine 10%. Cook ET (embryo transfer) catheter is used. . After introduction of the catheter into the cervix, a twenty milliliter syringe which will be prefilled with the distending media (saline) then fitted to the catheter. The speculum is removed and endovaginal probe is introduced in the posterior vaginal fornix
Other Name: (Sonoace 5000)
Device: three dimensional ultrasound
The uterus is visualized in the longitudinal plane, the ultrasound probe is kept steady and the patient is asked to lie still on the examination bed. The volume mode is switched on. Three D volume is generated by the automatic rotation of the mechanical transducer through 360º. The acquired volume is in the shape of a transacted cone with a depth of 4.3 - 8.6 cm and a vertical angle α = 90º. Using the medium line density, the typical acquisition time is a round 10 seconds
Other Name: (Medison, Voulson 530 D-MT ultrasound machine)
- detection of uterine lesion [ Time Frame: at time of hystroscopy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399501
|Cairo, Egypt, 12151|
|Principal Investigator:||Ahmed Maged, MD||Kasr Alainy medical school|