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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
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:
Prospective comparative study including 100 infertile patients with suspected uterine lesion. 2D ultrasound, sonohysterography , 3D ultrasound and hysteroscopy will be done to evaluate uterine cavity.

Condition or disease Intervention/treatment Phase
Infertility Procedure: hysteroscopy Device: two dimensional ultrasound Device: saline sonohysterography Device: three dimensional ultrasound Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: uterine lesion ultrasound, hysteroscopy
evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
Procedure: 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)




Primary Outcome Measures :
  1. detection of uterine lesion [ Time Frame: at time of hystroscopy ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected uterine factor of infertility

Exclusion Criteria:

  • tubal, ovarian or male factor of infertility

Information from the National Library of Medicine

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


Locations
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Egypt
Ahmed Maged
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school

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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02399501     History of Changes
Other Study ID Numbers: 132
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Keywords provided by Ahmed Maged, Cairo University:
2D ultrasound
3D ultrasound
sonohysterography
hysteroscopy
Uterine factor of infertility
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female