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Status unknownNCT05381376Updated Oct 31, 2022

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

An observational study in Database for Intrauterine Adhesion, Risk Factors for Intrauterine Adhesion and Risk Stratification and Prognostic Assessment, sponsored by Hua Duan. Status unknown at 2 sites in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-10-31.

Sponsored by Hua Duan · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,200
Ages
20 Years to 45 Years
Sex
Female
01

Study 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.
02

Conditions studied

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

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03

In context

Tissue Adhesions

241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's planned enrollment of 2,200 is above the median of 146 across 49 observational studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

This is the only study on the registry with Hua Duan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testHysteroscopy

    Hysteroscopy for CSGE, AFS, and endometrial receptivity assessment

  • Diagnostic testUltrasonography

    Ultrasonography for Uterus size and endometrial thickness

06

What researchers measure

Primary outcomes

  1. Rate of pregnancy

    Time frame: 2 years

Secondary outcomes

  1. Recurrence rate of IUA

    Recurrence rate of Intrauterine Adhesion

    Time frame: 3 month

  2. Menstrual blood volume

    Time frame: 3 month

  3. CSGE

    CSGE (Chinese Society of Gynaecological Endoscopy score), scale 0-28, higher scores mean a worse outcome

    Time frame: 3 month

  4. AFS

    AFS(American Fertility Association score), scale 1-12, higher scores mean a worse outcome

    Time frame: 3 month

07

Study locations

2 of 2 sites recruiting
  • Yishaofu Hospital
    Hangzhou, Zhejiang, China
    Recruiting
  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
    Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05381376
Lead sponsor
Hua Duan
Responsible party
Hua Duan (Director of Minimally Invasive Gynecologic Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Obstetrics and Gynecology Hospital) — Sponsor-investigator
First posted
May 19, 2022
Start date
Jan 20, 2018
Primary completion
Dec 20, 2023 (estimated)
Completion
Apr 20, 2024 (estimated)
Last update
Oct 31, 2022

Study contacts

Wang Sha, Dr.
Contact
wangsha1020@163.com
15201556908

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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