A comparison of Cook balloon and coil in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome

Completed

• Conditions: Asherman syndrome; Urological and Genital Diseases; Intrauterine synechiae

• Registration Number: ISRCTN69690272
• Lead Sponsor: Health Bureau of Zhejiang Province (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-15
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Woman with confirmed uterine adhesion with moderate or severe degree [American Fertility Society (AFS score range 5~12)] by hysteroscopic examination and history review for the first time in Sir Run Run Shaw hospital is to be recruited.
2. All the participants should be >=18 years and younger than 40 years old, having potential conceiving requirement

Exclusion Criteria

1. Older than 40 years old
2. The AFS score less than 5
3. Who doesn't want to get pregnant
4. Who has received hysteroscopic adhesive resection before
5. Who can't follow up according to the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 as representing severe adhesions.

Secondary Outcome Measures

Name	Time	Method
Pregnancy rates in both groups after surgery