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

October 27, 2022 updated by: Hua Duan
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Yishaofu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Taking α=0.05 and β=0.1, the overall time incidence (pregnancy rate) was taken as the lowest value of P=0.25, the risk factor (uterine adhesion fraction) coefficient was -0.18, and the decision coefficient for the risk factor (uterine adhesion fraction) was 0.8. The PASS software calculated 1622, taking into account the shedding factor (20%) and the randomization requirement of n=2028, based on each center's outpatient volume, the total number of cases to be included in this study database is at least 2200.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of pregnancy
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Duan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2018

Primary Completion (Anticipated)

December 20, 2023

Study Completion (Anticipated)

April 20, 2024

Study Registration Dates

First Submitted

May 8, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUADB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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