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Clinical Trials/NCT05381376
NCT05381376RecruitingNot Applicable

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

Hua Duan2 sites in 1 country2,200 target enrollmentStarted: January 20, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,200
Locations
2
Primary Endpoint
Rate of pregnancy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Hua Duan
Sponsor Class
Other
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

Study Sites (2)

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