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A randomized controlled trial on extending uterine balloon stent duration for treating severe intrauterine adhesion.

A randomized controlled trial on extending uterine balloon stent duration for treating severe intrauterine adhesion.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057089
Enrollment
Unknown
Registered
2022-02-27
Start date
2022-02-27
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrauterine adhesion

Interventions

The control group:After surgery, a uterine balloon is placed for 1 week.
The study group:After surgery, a uterine balloon is placed for 8 weeks.

Sponsors

Fuxing Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 38 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 20–38 years; 2. Desire to conceive; 3. Severe IUA (AFS score >= 9 and ESGE grade >= IV); 4. Willingness to undergo second-look and third-look hysteroscopies; 5. Written informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. Acute or untreated chronic genital tract inflammation; 2. Uterine malformations or uncorrected endocrine disorders; 3. History of tuberculosis or uterine artery embolization; 4. Failure to restore normal uterine cavity shape after surgery; 5. Contraindications for hormone therapy.

Design outcomes

Primary

MeasureTime frame
Incidence of adhesion reformation;

Secondary

MeasureTime frame
Incidence of adhesion reformation;Severity of intrauterine adhesion ;Improvement in menstrual volume;Endometrial thickness in the late follicular phase;The leukocyte count and vaginal discharge;Reproductive outcomes;

Countries

China

Contacts

Public ContactLuo Yiyang

Fuxing Hospital, Capital Medical University

luoyiyang2011@sina.com+86 138 1024 5053

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026