Sonohysterography and 3D Ultrasonography Versus Diagnostic Hysteroscopy in Assessment of Uterine Factor in Cases of Female Infertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- detection of uterine lesion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Suspected uterine factor of infertility
排除标准
- •tubal, ovarian or male factor of infertility
研究组 & 干预措施
uterine lesion ultrasound, hysteroscopy
evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
干预措施: hysteroscopy (Procedure)
uterine lesion ultrasound, hysteroscopy
evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
干预措施: two dimensional ultrasound (Device)
uterine lesion ultrasound, hysteroscopy
evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
干预措施: saline sonohysterography (Device)
uterine lesion ultrasound, hysteroscopy
evaluation of female with proved uterine lesion by two dimensional ultrasound, three dimensional ultrasound, saline sonohysterography and hysteroscopy
干预措施: three dimensional ultrasound (Device)
结局指标
主要结局
detection of uterine lesion
时间窗: at time of hystroscopy
次要结局
未报告次要终点
研究者
Ahmed Maged
Assistant professor
Cairo University
