Database for Intrauterine AdhesionNCT05381376
Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion
An observational study of Database for Intrauterine Adhesion and Risk Factors for Intrauterine Adhesion, run by Hua Duan at 2 sites in China.
Trial summary
1. To establish a follow-up database for uterine adhesions and a library of biological specimens for Intrauterine Adhesion. 2. using epidemiological surveys and biological analyses to screen risk factors for the development and prognosis of Intrauterine Adhesion. 3. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Database for Intrauterine Adhesion, Risk Factors for Intrauterine Adhesion, Risk Stratification and Prognostic Assessment
- What is being tested?
- Hysteroscopy and Ultrasonography
- How many people
- 2,200 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jan 2018to 20 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Taking α=0.05 and β=0.1, the overall time incidence (pregnancy rate) was taken as the lowest value of P=0.25, the risk factor (uterine adhesion fraction) coefficient was -0.18, and the decision coefficient for the risk factor (uterine adhesion fraction) was 0.8. The PASS software calculated 1622, taking into account the shedding factor (20%) and the randomization requirement of n=2028, based on each center's outpatient volume, the total number of cases to be included in this study database is at least 2200.
Who may be able to join
- Previously diagnostic hysteroscopy confirmed adhesions combined with infertility or recurrent pregnancy loss (early pregnancy loss >2)
- Desiring to conceive
- Ages between 20-45 years;
- Patients without gynecological endocrine disorders (e.g. PCOS) and AMH>1ng/ml;
- Signing informed consent.
Who cannot join
- Hysteroscopy contraindications;
- Hormone therapy contraindications;
- Pregnancy contraindications;
- History of malignant pelvic tumor and radiotherapy;
- Severe hepatic or renal dysfunction;
- Complicated with hematological disorders (eg.platelet dysfunction, severe anemia, blood-borne infections);
- Male factor infertility(eg.seminal abnormalities).
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing
Bohan Li, Dr., +8613132153361, 24713144@qq.com
- Recruiting
Yishaofu Hospital
Hangzhou, Zhejiang
Songying Zhang, Prof., 17370491790, gmis_fkwc@163.com
About this study
- To establish a follow-up database for uterine adhesions and a library of biological specimens for Intrauterine Adhesion. 2. using epidemiological surveys and biological analyses to screen risk factors for the development and prognosis of Intrauterine Adhesion. 3. Predictive models based on clinical and biochemical indicators, specimen testing and hysteroscopic images are also combined with statistical analysis and machine learning algorithms to enable patients' risk stratification and prognostic assessment.
- Conditions
- Database for Intrauterine Adhesion, Risk Factors for Intrauterine Adhesion, Risk Stratification and Prognostic Assessment, Intrauterine Adhesion
- Being tested
- Hysteroscopy, Ultrasonography
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyDiagnostic test
Hysteroscopy for CSGE, AFS, and endometrial receptivity assessment
UltrasonographyDiagnostic test
Ultrasonography for Uterus size and endometrial thickness
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pregnancy
Measured: 2 years
Secondary outcomes (4)
Recurrence rate of IUA
Recurrence rate of Intrauterine Adhesion
Measured: 3 month
Menstrual blood volume
Measured: 3 month
CSGE
CSGE (Chinese Society of Gynaecological Endoscopy score), scale 0-28, higher scores mean a worse outcome
Measured: 3 month
AFS
AFS(American Fertility Association score), scale 1-12, higher scores mean a worse outcome
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start20 Jan 2018
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Database for Intrauterine AdhesionStudies of the same condition, open and under way.
- 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
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Duan, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381376
- Sponsor's protocol ID
- IUADB
- Status last verified
- Oct 2022
- First submitted
- 8 May 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li B, Chen H, Duan H. Visualized hysteroscopic artificial intelligence fertility assessment system for endometrial injury: an image-deep-learning study. Ann Med. 2025 Dec;57(1):2478473. doi: 10.1080/07853890.2025.2478473. Epub 2025 Mar 17.
PubMed 40098308
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion
- ClinicalTrials.gov ID
- NCT05381376
- Acronym / sponsor ID
- IUADB
- Conditions
- Database for Intrauterine Adhesion, Risk Factors for Intrauterine Adhesion, Risk Stratification and Prognostic Assessment, Intrauterine Adhesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Hua DuanUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 19 May 2022 (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.
- To establish a follow-up database for uterine adhesions and a library of biological specimens for Intrauterine Adhesion. 2. using epidemiological surveys and biological analyses to screen risk factors for the development and prognosis of Intrauterine Adhesion. 3. Predictive models based on clinical and biochemical indicators, specimen testing and hysteroscopic images are also combined with statistical analysis and machine learning algorithms to enable patients' risk stratification and prognostic assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Taking α=0.05 and β=0.1, the overall time incidence (pregnancy rate) was taken as the lowest value of P=0.25, the risk factor (uterine adhesion fraction) coefficient was -0.18, and the decision coefficient for the risk factor (uterine adhesion fraction) was 0.8. The PASS software calculated 1622, taking into account the shedding factor (20%) and the randomization requirement of n=2028, based on each center's outpatient volume, the total number of cases to be included in this study database is at least 2200.
Key inclusion criteria (5 listed)
- Previously diagnostic hysteroscopy confirmed adhesions combined with infertility or recurrent pregnancy loss (early pregnancy loss >2)
- Desiring to conceive
- Ages between 20-45 years;
- Patients without gynecological endocrine disorders (e.g. PCOS) and AMH>1ng/ml;
- Signing informed consent.
Key exclusion criteria (7 listed)
- Hysteroscopy contraindications;
- Hormone therapy contraindications;
- Pregnancy contraindications;
- History of malignant pelvic tumor and radiotherapy;
- Severe hepatic or renal dysfunction;
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 |
|---|---|---|
| HysteroscopyHysteroscopy for CSGE, AFS, and endometrial receptivity assessment | Diagnostic test | – |
| UltrasonographyUltrasonography for Uterus size and endometrial thickness | Diagnostic test | – |
Primary outcome
Rate of pregnancy
Time frame: 2 years
4 secondary outcomes
Recurrence rate of IUA
Time frame: 3 month
Menstrual blood volume
Time frame: 3 month
CSGE
Time frame: 3 month
AFS
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Derived from this study: PubMed 40098308Li B, Chen H, Duan H. Visualized hysteroscopic artificial intelligence fertility assessment system for endometrial injury: an image-deep-learning study. Ann Med. 2025 Dec;57(1):2478473. doi: 10.1080/07853890.2025.2478473. Epub 2025 Mar 17.
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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Database for Intrauterine Adhesion and Risk Factors for Intrauterine Adhesion, run by Hua Duan at 2 sites 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Sha, Dr. (15201556908, wangsha1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pregnancy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05381376, which also lists 1 linked publication.
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 31 Oct 2022.