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Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion

Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05381376
Enrollment
2200
Registered
2022-05-19
Start date
2018-01-20
Completion date
2024-04-20
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Database for Intrauterine Adhesion, Intrauterine Adhesion, Risk Factors for Intrauterine Adhesion, Risk Stratification and Prognostic Assessment

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTHysteroscopy

Hysteroscopy for CSGE, AFS, and endometrial receptivity assessment

DIAGNOSTIC_TESTUltrasonography

Ultrasonography for Uterus size and endometrial thickness

Sponsors

Hua Duan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frame
Rate of pregnancy2 years

Secondary

MeasureTime frameDescription
Recurrence rate of IUA3 monthRecurrence rate of Intrauterine Adhesion
Menstrual blood volume3 month
CSGE3 monthCSGE (Chinese Society of Gynaecological Endoscopy score), scale 0-28, higher scores mean a worse outcome
AFS3 monthAFS(American Fertility Association score), scale 1-12, higher scores mean a worse outcome

Countries

China

Contacts

Primary ContactWang Sha, Dr.
wangsha1020@163.com15201556908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026