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

Hua Duan

Status: Enrolling

Conditions: Risk Stratification and Prognostic Assessment; Risk Factors for Intrauterine Adhesion; Database for Intrauterine Adhesion; Intrauterine Adhesion

Treatments: Diagnostic Test: Hysteroscopy; Diagnostic Test: Ultrasonography

Study type: Observational

Funder types: Other

Identifiers

NCT05381376

IUADB

Details and patient eligibility

About

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.

Enrollment: 2,200 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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).