跳至主要内容
临床试验/NCT07416591
NCT07416591招募中不适用

Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women

Sohag University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年10月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Diagnostic Accuracy of saline infusion sonohysterography (SIS): sensitivity,specificity, positive predictive value(PPV) and negative predictive value (NPV) for detecting pelvic Adhesions compared to Laparoscopy in infertile women

研究概览

简要总结

Infertility is agrowing concern affecting million of couples worldwide,with infertility being asignificant subset, infertility is define as inability to achieve pregnancy after one year of regular unprotected sexual intercours Among these , pelvic Adhesions present amajor challenge in reproductive medicine as they can lead to tubal occulsion and uterine cavity distortion Saline infusion sonohysterography (SIS)has emerged as minimally invasive,cost effected,and well tolerated alternative for assessing uterine and tubal abnormalities in infertile patient SIS involve the introduction of sterile saline into the uterine cavity under ultrasound guidance ,enhancing the visualization of Endometrial lining, intrauterine abnormalities and tubal patency,compared to HSG, SIS offer several advantages including the avoidance of radiation exposure, better patient comfort and the ability to stimultaneously assess the myometrium and adenxal structure

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • infertile women aged 18-45yr Patient suspected to have pelvic Adhesions Women with normal ovulatory function and normal husband semen analysis

排除标准

  • active pelvic infection or abnormal vaginal bleeding Pt with cervical stenosis Congenital uterine mullerian anomalies Pt with pelvic malignancy

研究组 & 干预措施

Infertile women with pelvic Adhesions

Experimental

Infetile women with pelvic Adhesions ond normal ovulatory function and normal husband semen analysis

干预措施: Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women (Diagnostic Test)

结局指标

主要结局

Diagnostic Accuracy of saline infusion sonohysterography (SIS): sensitivity,specificity, positive predictive value(PPV) and negative predictive value (NPV) for detecting pelvic Adhesions compared to Laparoscopy in infertile women

时间窗: One year

dorsolithotomy position and Speculum insertion into vagina and catheter insetion into uterine cavity inflated with 1\_2ml of saline to secure placement with infusion of 10\_20 ml of sterile saline into uterine cavity through the catheter while performing transvaginal ultrasound imaging

次要结局

  • Uterune and tubal findings: presence of tubal blockage, hydrosalpinx or peritoneal adhesions(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Sabry Abdelkarim

Resident of Obestetrics and gynacology department Sohag University hospital

Sohag University

研究点 (1)

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