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

Recruiting

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

• Registration Number: NCT05381376
• Lead Sponsor: Hua Duan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-20
• Study First Submitted: 2022-05-08
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31
• Primary Completion: 2023-12-20
• Study Completion: 2024-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of pregnancy	2 years

Secondary Outcome Measures

Name	Time	Method
Recurrence rate of IUA	3 month	Recurrence rate of Intrauterine Adhesion
Menstrual blood volume	3 month
CSGE	3 month	CSGE (Chinese Society of Gynaecological Endoscopy score), scale 0-28, higher scores mean a worse outcome
AFS	3 month	AFS(American Fertility Association score), scale 1-12, higher scores mean a worse outcome

Trial Locations

Locations (2)

Yishaofu Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Obstetrics and Gynecology Hospital, Capital Medical University; 🇨🇳 Beijing, China