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

Intrauterine Adhesion Clinical Trial

Official title:

Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03330873
• Other study ID #: No.3-20140601
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2017
• Last updated: October 31, 2017
• Start date: October 23, 2017
• Est. completion date: October 20, 2018

Study information

• Verified date: October 2017
• Source: Beijing Obstetrics and Gynecology Hospital
• Contact: Zhu Ru, MD
• Phone: +8613966636438
• Email: zhuru19790202[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• disposable balloon uterine stent
The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter
• Foley catheter
Foley catheter can partly separate the sides of uterus wall.

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Obstetrics and Gynecology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	second diagnostic hysteroscopy	AFS score(The American Fertility Society classifications)	Within the first 3 months after surgery
Secondary	Menstruation Pattern	Improvement or No Significant Change	Within the first 3 months after surgery
Secondary	Number of participants with pregnancy	Number of biochemical pregnancies and clinical pregnancies	one year