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Clinical Trials/NCT05381376
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

  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.
Registry
clinicaltrials.gov
Start Date
January 20, 2018
End Date
April 20, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hua Duan
Responsible Party
Sponsor Investigator
Principal Investigator

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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