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Clinical Trials/NCT02399501
NCT02399501CompletedNot Applicable

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

Cairo University2 sites in 1 country100 target enrollmentStarted: March 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
detection of uterine lesion

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Suspected uterine factor of infertility

Exclusion Criteria

  • tubal, ovarian or male factor of infertility

Outcomes

Primary Outcomes

detection of uterine lesion

Time Frame: at time of hystroscopy

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Maged

Assistant professor

Cairo University

Study Sites (2)

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