Sonohysterography , 3D Ultrasonography and Hysteroscopy in Assessment of Uterine Factor in Cases of Female Infertility

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: hysteroscopy; Device: two dimensional ultrasound; Device: saline sonohysterography; Device: three dimensional ultrasound

• Registration Number: NCT02399501
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-21
• Study First Posted: 2015-03-26
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-18
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Suspected uterine factor of infertility

Exclusion Criteria

• tubal, ovarian or male factor of infertility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
uterine lesion ultrasound, hysteroscopy	three dimensional ultrasound	evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
uterine lesion ultrasound, hysteroscopy	two dimensional ultrasound	evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
uterine lesion ultrasound, hysteroscopy	hysteroscopy	evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
uterine lesion ultrasound, hysteroscopy	saline sonohysterography	evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy

Primary Outcome Measures

Name	Time	Method
detection of uterine lesion	at time of hystroscopy

Trial Locations

Locations (1)

Ahmed Maged; 🇪🇬 Cairo, Egypt