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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: hysteroscopy; Device: two dimensional ultrasound; Device: saline sonohysterography; Device: three dimensional ultrasound

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Ahmed Maged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Suspected uterine factor of infertility

Exclusion Criteria:

• tubal, ovarian or male factor of infertility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: (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 Names: (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 Names: (Medison, Voulson 530 D-MT ultrasound machine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
detection of uterine lesion	at time of hystroscopy

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: March 5, 2015
• First Submitted That Met QC Criteria: March 21, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 18, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: hysteroscopy; 3D ultrasound; 2D ultrasound; sonohysterography; Uterine factor of infertility
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 132