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

Intrauterine Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381376
• Other study ID #: IUADB
• Status: Recruiting
• Start date: January 20, 2018
• Est. completion date: April 20, 2024

Study information

• Verified date: October 2022
• Source: Beijing Obstetrics and Gynecology Hospital
• Contact: Wang Sha, Dr.
• Phone: 15201556908
• Email: wangsha1020[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: April 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Diagnostic Test:
• Hysteroscopy
Hysteroscopy for CSGE, AFS, and endometrial receptivity assessment
• Ultrasonography
Ultrasonography for Uterus size and endometrial thickness

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital, Capital Medical University	Beijing
China	Yishaofu Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hua Duan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of pregnancy		2 years
Secondary	Recurrence rate of IUA	Recurrence rate of Intrauterine Adhesion	3 month
Secondary	Menstrual blood volume		3 month
Secondary	CSGE	CSGE (Chinese Society of Gynaecological Endoscopy score), scale 0-28, higher scores mean a worse outcome	3 month
Secondary	AFS	AFS(American Fertility Association score), scale 1-12, higher scores mean a worse outcome	3 month