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

Study Overview

• Status: Recruiting
• Conditions: Infertile Women With Pelvic Adhesions
• Intervention / Treatment: Diagnostic test: Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag Governorate
    • Sohag, Sohag Governorate, Egypt
      • Recruiting
      • Sohag University Hospital
      • Contact: Magdy M Amin, Professor; Phone Number: +20934602963; Email: ethics@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

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: Infertile women with pelvic Adhesions; Infetile women with pelvic Adhesions ond normal ovulatory function and normal husband semen analysis	Diagnostic test: Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women; Introduction of sterile saline into uterine cavity under ultrasound guidance to detect endometial lining and tubal patency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterune and tubal findings: presence of tubal blockage, hydrosalpinx or peritoneal adhesions	Infusion of saline intrauterine undertransvaginal ultrasound imaging for detection of tubal block or peritoneal adhesions in infertile women	One year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Sohag_Med__25_9_7MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No