InfertilityNCT07610668
Clinical Value of Saline Infusion Sonohysterography in the Assessment of Cesarean Scar Defects
An observational study of Infertility, run by Tang-Du Hospital at 1 site in China.
Trial summary
This study selected patients who underwent cesarean section and were scheduled to undergo Saline Infusion Sonohysterography (SIS) for evaluating the structure of the incision. Clinical characteristics and clinical symptoms were collected. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- diverticulum reconstruction surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Jul 2026
- Phase
- Observational
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The research population comprised adult women with a prior cesarean delivery who presented to Tangdu Hospital with symptoms including abnormal uterine bleeding, dysmenorrhea, prolonged menstrual spotting, or secondary infertility.
Who may be able to join
- More than 6 months after cesarean delivery;
- Presenting with clinical symptoms-including abnormal uterine bleeding, dysmenorrhea, prolonged menstrual spotting, or secondary infertility;
- Requiring saline infusion sonohysterography (SIS) to evaluate the cesarean scar.
Who cannot join
- Multiple cesarean deliveries;
- Patients contraindicated for saline infusion sonohysterography (SIS), including pregnancy or suspected pregnancy, failure to meet vaginal hygiene criteria, inability to cooperate during the procedure, or suboptimal image quality;
- Cases with incomplete clinical data or lost to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tang-Du Hospital
Xi'an, Shaanxi, 710038
Li Zhang, MD, 86-29-84778860, lilyzhang319_20@hotmail.com
Jing Ma, MM, +86-15529398263, 178937707@qq.com
About this study
Official title: Preliminary Clinical Application Study of Saline Infusion Onohysterography in Structure of Cesarean Scar Surgery
This study selected patients who underwent cesarean section and were scheduled to undergo Saline Infusion Sonohysterography (SIS) for evaluating the structure of the incision. Clinical characteristics and clinical symptoms were collected. Combined with hysteroscopy, MRI, conventional ultrasound and SIS examination results, the study analyzed the detection rate of cesarean section diverticula by SIS, the changes in diverticulum size and the diagnostic efficacy of residual muscle layer thickness at the incision site. The surgical methods and clinical symptom improvement of patients with CSD after surgery were followed up for half a year to one year. The study aimed to clarify the guiding value of SIS in clinical decision-making and patient prognosis for patients, and to analyze the etiological relationship between the true incidence of CSD and clinical complications. Thus, it provided evidence-based basis for clinical events of cesarean section surgery → CSD → CSD complications → surgical treatment of CSD → patient prognosis, promoting the progress of precise diagnosis and treatment of female reproductive health.
Read the detailed description
Background and Rationale:
The precise assessment of the structure of the cesarean section incision is the core of achieving "individualized surgery". Through multi-dimensional analysis of anatomical structure, functional status, and patient needs, one can precisely select hysteroscopy, laparoscopy, or combined surgical methods, significantly improving symptom relief rate, diverticulum closure rate, and reducing the risks of recurrence and pregnancy complications. However, preoperative precise diagnosis is the prerequisite for treatment. The SIS technology can obtain a good acoustic window through a simple uterine cavity water injection method, clearly displaying the structure of the cesarean section incision, enhancing the diagnostic confidence of ultrasound doctors, providing more detailed diagnoses for patients and clinicians, and is expected to replace diagnostic hysteroscopy operations. In the future, it is necessary to promote the standardization of assessment and technology transformation, ultimately achieving the leap from "treatment based on symptoms" to "precise repair" of CSD, improving the long-term prognosis of patients.
Study Design and Methodology:
This is a single-center, prospective, observational cohort study. The objective is to To explore the diagnostic value of the acoustic contrast imaging technique using normal saline for the uterine cavity in the assessment of the incision structure after cesarean section.
This study included patients who were scheduled for cesarean section for secondary infertility from January 2023 to July 2025 as the research subjects. General clinical data of the patients were collected, including age, history of cesarean section, gynecological history, time of secondary infertility, whether there was excessive menstrual bleeding or dysmenorrhea, etc.
Data Collection and Assessments:
This study included patients who were scheduled for cesarean section for secondary infertility from January 2023 to July 2025 as the research subjects. General clinical data of the patients were collected, including age, history of cesarean section, gynecological history, time of secondary infertility, whether there was excessive menstrual bleeding or dysmenorrhea, etc.The primary ultrasonographic parameters to be recorded include:
During TVUS, assess whether a diverticulum is present at the cesarean section incision site. If identified, measure its longitudinal diameter, transverse diameter, depth, residual myometrial thickness, and the distance from the lower margin of the diverticulum to the external cervical os, in accordance with international consensus guidelines. During SIS, evaluate the presence of a diverticulum. In cases where a diverticulum is detected, apply the conventional TVUS measurement protocol to quantify all relevant dimensions and assess for associated complications-including cysts or polyps-as well as overall uterine cavity morphology. Concurrently, collect MRI and hysteroscopy findings.
Follow-up and Endpoints:
Following surgical intervention, participants will undergo longitudinal follow-up, including documentation of the surgical approach, clinical symptom status at 6 months postoperatively, and pregnancy outcomes at 12 months postoperatively. Analyze the aggregated data to determine the clinical decision-making utility of SIS.
- Conditions
- Infertility
- Being tested
- diverticulum reconstruction surgery
- Keywords
- Saline Infusion Sonohysterography, Transvaginal ultrasonography, Cesarean scar diverticulum, Residual myometrial thickness
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diverticulum reconstruction surgeryProcedure or surgery
This group of patients received conventional infertility treatment only, without undergoing diverticulum reconstruction surgery, in accordance with standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| This group of patients received appropriate treatment based on the presence or absence of diverticul | The treatment plan was determined by the attending physician according to clinical guidelines and was strictly independent of this observational study protocol. Receives: Procedure: diverticulum reconstruction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of cesarean scar diverticulum
The detection rate of cesarean scar diverticulum refers to the proportion of patients in whom the diverticulum is identified through various diagnostic modalities among all patients examined.
Measured: Day 1
Clinical Pregnancy Rate
The clinical pregnancy rate is defined as the proportion of patients with the presence of at least one intrauterine gestational sac with a visible fetal heartbeat, confirmed by transvaginal ultrasound.
Measured: Up to 90 days of gestation
Residual myometrial thickness
The Residual myometrial thickness refers to the thickness of the myometrial layer at the uterine lower segment at the site of prior cesarean delivery.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jan 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Tang-Du Hospital
- Investigators
- Li Zhang, MD, Principal investigator, The Second Affiliated Hospital of Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610668
- Sponsor's protocol ID
- K202604-36
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the published article will be shared. Data will be available to researchers who provide a methodologically sound proposal, purely for the purpose of achieving the aims in the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Application Study of Saline Infusion Onohysterography in Structure of Cesarean Scar Surgery
- ClinicalTrials.gov ID
- NCT07610668
- Acronym / sponsor ID
- K202604-36
- Conditions
- Infertility
- Keywords
- Saline Infusion Sonohysterography, Transvaginal ultrasonography, Cesarean scar diverticulum, Residual myometrial thickness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 May 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.
This study selected patients who underwent cesarean section and were scheduled to undergo Saline Infusion Sonohysterography (SIS) for evaluating the structure of the incision. Clinical characteristics and clinical symptoms were collected. Combined with hysteroscopy, MRI, conventional ultrasound and SIS examination results, the study analyzed the detection rate of cesarean section diverticula by SIS, the changes in diverticulum size and the diagnostic efficacy of residual muscle layer thickness at the incision site. The surgical methods and clinical symptom improvement of patients with CSD after surgery were followed up for half a year to one year. The study aimed to clarify the guiding value of SIS in clinical decision-making and patient prognosis for patients, and to analyze the etiological relationship between the true incidence of CSD and clinical complications. Thus, it provided evidence-based basis for clinical events of cesarean section surgery → CSD → CSD complications → surgical treatment of CSD → patient prognosis, promoting the progress of precise diagnosis and treatment of female reproductive health.
Detailed description
Background and Rationale:
The precise assessment of the structure of the cesarean section incision is the core of achieving "individualized surgery". Through multi-dimensional analysis of anatomical structure, functional status, and patient needs, one can precisely select hysteroscopy, laparoscopy, or combined surgical methods, significantly improving symptom relief rate, diverticulum closure rate, and reducing the risks of recurrence and pregnancy complications. However, preoperative precise diagnosis is the prerequisite for treatment. The SIS technology can obtain a good acoustic window through a simple uterine cavity water injection method, clearly displaying the structure of the cesarean section incision, enhancing the diagnostic confidence of ultrasound doctors, providing more detailed diagnoses for patients and clinicians, and is expected to replace diagnostic hysteroscopy operations. In the future, it is necessary to promote the standardization of assessment and technology transformation, ultimately achieving the leap from "treatment based on symptoms" to "precise repair" of CSD, improving the long-term prognosis of patients.
Study Design and Methodology:
This is a single-center, prospective, observational cohort study. The objective is to To explore the diagnostic value of the acoustic contrast imaging technique using normal saline for the uterine cavity in the assessment of the incision structure after cesarean section.
This study included patients who were scheduled for cesarean section for secondary infertility from January 2023 to July 2025 as the research subjects. General clinical data of the patients were collected, including age, history of cesarean section, gynecological history, time of secondary infertility, whether there was excessive menstrual bleeding or dysmenorrhea, etc.
Data Collection and Assessments:
This study included patients who were scheduled for cesarean section for secondary infertility from January 2023 to July 2025 as the research subjects. General clinical data of the patients were collected, including age, history of cesarean section, gynecological history, time of secondary infertility, whether there was excessive menstrual bleeding or dysmenorrhea, etc.The primary ultrasonographic parameters to be recorded include:
During TVUS, assess whether a diverticulum is present at the cesarean section incision site. If identified, measure its longitudinal diameter, transverse diameter, depth, residual myometrial thickness, and the distance from the lower margin of the diverticulum to the external cervical os, in accordance with international consensus guidelines. During SIS, evaluate the presence of a diverticulum. In cases where a diverticulum is detected, apply the conventional TVUS measurement protocol to quantify all relevant dimensions and assess for associated complications-including cysts or polyps-as well as overall uterine cavity morphology. Concurrently, collect MRI and hysteroscopy findings.
Follow-up and Endpoints:
Following surgical intervention, participants will undergo longitudinal follow-up, including documentation of the surgical approach, clinical symptom status at 6 months postoperatively, and pregnancy outcomes at 12 months postoperatively. Analyze the aggregated data to determine the clinical decision-making utility of SIS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This group of patients received appropriate treatment based on the presence or absence of diverticul | – | Procedure: diverticulum reconstruction surgeryThe treatment plan was determined by the attending physician according to clinical guidelines and was strictly independent of this observational study protocol. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The research population comprised adult women with a prior cesarean delivery who presented to Tangdu Hospital with symptoms including abnormal uterine bleeding, dysmenorrhea, prolonged menstrual spotting, or secondary infertility.
Key inclusion criteria (3 listed)
- More than 6 months after cesarean delivery;
- Presenting with clinical symptoms-including abnormal uterine bleeding, dysmenorrhea, prolonged menstrual spotting, or secondary infertility;
- Requiring saline infusion sonohysterography (SIS) to evaluate the cesarean scar.
Key exclusion criteria (3 listed)
- Multiple cesarean deliveries;
- Patients contraindicated for saline infusion sonohysterography (SIS), including pregnancy or suspected pregnancy, failure to meet vaginal hygiene criteria, inability to cooperate during the procedure, or suboptimal image quality;
- Cases with incomplete clinical data or lost to follow-up.
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 |
|---|---|---|
| diverticulum reconstruction surgeryThis group of patients received conventional infertility treatment only, without undergoing diverticulum reconstruction surgery, in accordance with standard clinical practice. | Procedure or surgery | This group of patients received appropriate treatment based on the presence or absence of diverticul |
Primary outcome
The detection rate of cesarean scar diverticulum
Time frame: Day 1
The detection rate of cesarean scar diverticulum refers to the proportion of patients in whom the diverticulum is identified through various diagnostic modalities among all patients examined.
Clinical Pregnancy Rate
Time frame: Up to 90 days of gestation
The clinical pregnancy rate is defined as the proportion of patients with the presence of at least one intrauterine gestational sac with a visible fetal heartbeat, confirmed by transvaginal ultrasound.
Residual myometrial thickness
Time frame: Day 1
The Residual myometrial thickness refers to the thickness of the myometrial layer at the uterine lower segment at the site of prior cesarean delivery.
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 28 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the published article will be shared. Data will be available to researchers who provide a methodologically sound proposal, purely for the purpose of achieving the aims in the approved proposal.
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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.
Li Zhang, MD principal investigator
The Second Affiliated Hospital of Air Force Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Tang-Du Hospital at 1 site in China.
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 3 inclusion and 3 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 28 May 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 China. 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?
Contact Li Zhang, MD (86-29-84778860, lilyzhang319_20@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of cesarean scar diverticulum (time frame: Day 1). The study lists 3 primary outcomes in all. 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 28 May 2026.