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

Hua Duan2,200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,200

Conditions

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

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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).

Locations (2)

Yishaofu Hospital

Hangzhou, Zhejiang, China

RECRUITING

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Rate of pregnancy

Time frame: 2 years

Secondary Outcomes

Recurrence rate of IUA

Recurrence rate of Intrauterine Adhesion

Time frame: 3 month

Menstrual blood volume

Time frame: 3 month

CSGE

CSGE (Chinese Society of Gynaecological Endoscopy score), scale 0-28, higher scores mean a worse outcome

Time frame: 3 month

AFS

AFS(American Fertility Association score), scale 1-12, higher scores mean a worse outcome

Time frame: 3 month

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts