NCT05381376
Recruiting
Not Applicable
Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion
Hua Duan2 sites in 1 country2,200 target enrollmentJanuary 20, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Database for Intrauterine Adhesion
- Sponsor
- Hua Duan
- Enrollment
- 2200
- Locations
- 2
- Primary Endpoint
- Rate of pregnancy
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
- 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.
Investigators
Hua Duan
Director of Minimally Invasive Gynecologic Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing Obstetrics and Gynecology Hospital
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Rate of pregnancy
Time Frame: 2 years
Secondary Outcomes
- Recurrence rate of IUA(3 month)
- Menstrual blood volume(3 month)
- CSGE(3 month)
- AFS(3 month)
Study Sites (2)
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