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NCT Number: NCT07416591

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

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

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University hospital

Sohag, Sohag Governorate, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, Professor

CONTACT

[email protected]

+20934602963

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women

Diagnostic Test

Introduction of sterile saline into uterine cavity under ultrasound guidance to detect endometial lining and tubal patency

Primary outcomes

  1. 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

    Time frame: 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

Secondary outcomes

  1. Uterune and tubal findings: presence of tubal blockage, hydrosalpinx or peritoneal adhesions

    Time frame: One year

    Infusion of saline intrauterine undertransvaginal ultrasound imaging for detection of tubal block or peritoneal adhesions in infertile women

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.