Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion
1 other identifier
observational
2,200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2018
CompletedFirst Submitted
Initial submission to the registry
May 8, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2024
CompletedOctober 31, 2022
October 1, 2022
5.9 years
May 8, 2022
October 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of pregnancy
2 years
Secondary Outcomes (4)
Recurrence rate of IUA
3 month
Menstrual blood volume
3 month
CSGE
3 month
AFS
3 month
Interventions
Hysteroscopy for CSGE, AFS, and endometrial receptivity assessment
Ultrasonography for Uterus size and endometrial thickness
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hua Duanlead
Study Sites (2)
Yishaofu Hospital
Hangzhou, Zhejiang, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Minimally Invasive Gynecologic Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Study Record Dates
First Submitted
May 8, 2022
First Posted
May 19, 2022
Study Start
January 20, 2018
Primary Completion
December 20, 2023
Study Completion
April 20, 2024
Last Updated
October 31, 2022
Record last verified: 2022-10