Infertile Women With Pelvic AdhesionsNCT07416591
Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women
A study testing Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women in people with Infertile Women With Pelvic Adhesions, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertile Women With Pelvic Adhesions
- What is being tested?
- Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile women aged 18-45yr Patient suspected to have pelvic Adhesions Women with normal ovulatory function and normal husband semen analysis
Who cannot join
- active pelvic infection or abnormal vaginal bleeding Pt with cervical stenosis Congenital uterine mullerian anomalies Pt with pelvic malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospital
Sohag, Sohag Governorate
Magdy M Amin, Professor, +20934602963, ethics@med.sohag.edu.eg
About this study
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
- Conditions
- Infertile Women With Pelvic Adhesions
- Being tested
- Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile womenDiagnostic test
Introduction of sterile saline into uterine cavity under ultrasound guidance to detect endometial lining and tubal patency
| Study group | Role | What they receive |
|---|---|---|
| Infertile women with pelvic Adhesions | Experimental | Infetile women with pelvic Adhesions ond normal ovulatory function and normal husband semen analysis Receives: Diagnostic Test: Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Women With Pelvic AdhesionsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Sabry Abdelkarim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416591
- Sponsor's protocol ID
- Sohag_Med__25_9_7MS
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women
- ClinicalTrials.gov ID
- NCT07416591
- Acronym / sponsor ID
- Sohag_Med__25_9_7MS
- Conditions
- Infertile Women With Pelvic Adhesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile women with pelvic Adhesions | Experimental | Diagnostic Test: Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile womenInfetile women with pelvic Adhesions ond normal ovulatory function and normal husband semen analysis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women aged 18-45yr Patient suspected to have pelvic Adhesions Women with normal ovulatory function and normal husband semen analysis
Key exclusion criteria (1 listed)
- active pelvic infection or abnormal vaginal bleeding Pt with cervical stenosis Congenital uterine mullerian anomalies Pt with pelvic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile womenIntroduction of sterile saline into uterine cavity under ultrasound guidance to detect endometial lining and tubal patency | Diagnostic test | Infertile women with pelvic Adhesions |
Primary outcome
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
1 secondary outcome
Uterune and tubal findings: presence of tubal blockage, hydrosalpinx or peritoneal adhesions
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline infusion sonohysterography in Detection of pelvic Adhesions in infertile women in people with Infertile Women With Pelvic Adhesions, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.