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

NCT ID: NCT05381376

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-20

Study Completion Date

2024-04-20

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Hysteroscopy

Hysteroscopy for CSGE, AFS, and endometrial receptivity assessment

Intervention Type DIAGNOSTIC_TEST

Ultrasonography

Ultrasonography for Uterus size and endometrial thickness

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hua Duan

OTHER

Sponsor Role lead

Responsible Party

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Hua Duan

Director of Minimally Invasive Gynecologic Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Yishaofu Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wang Sha, Dr.

Role: CONTACT

15201556908

Facility Contacts

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Songying Zhang, Prof.

Role: primary

17370491790

Bohan Li, Dr.

Role: primary

+8613132153361

Other Identifiers

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IUADB

Identifier Type: -

Identifier Source: org_study_id

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