The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome

Not Applicable

• Conditions: Intrauterine Adhesion
• Interventions: Device: disposable balloon uterine stent; Device: Foley catheter

• Registration Number: NCT03330873
• Lead Sponsor: Beijing Obstetrics and Gynecology Hospital

Brief Summary

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.

Detailed Description

The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-18
• Study Start: 2017-10-23
• Study First Submitted QC: 2017-10-31
• Last Update Submitted: 2017-10-31
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2018-08-20
• Study Completion: 2018-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• age 20-40 years;
• Moderate to severe intrauterine adhesion (AFS score ≥5）;
• complains of menstruation disorder and reproductive dysfunction
• Agreement to have second-look hysteroscopy
• informed consent

Exclusion Criteria

• ovarian failure
• patients who did not proceed to second-look hysteroscopy within the specified time frame
• Contraindication of hormone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disposable balloon uterine stent	disposable balloon uterine stent	After the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery.
Foley catheter	Foley catheter	After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.

Primary Outcome Measures

Name	Time	Method
second diagnostic hysteroscopy	Within the first 3 months after surgery	AFS score（The American Fertility Society classifications）

Secondary Outcome Measures

Name	Time	Method
Menstruation Pattern	Within the first 3 months after surgery	Improvement or No Significant Change
Number of participants with pregnancy	one year	Number of biochemical pregnancies and clinical pregnancies

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China