A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis
Phase: NA
Conditions: Asherman Syndrome
Sponsor: Wenzhou Medical University

Cover Page 
Official title of the study: A Randomized Clinical Trial to 
Assess the Efficacy of Intrauterine Balloon Compared to 
Intrauterine Contraceptive Device Plus Foley Catheter in the 
Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis. 
Date: 12/01/2017 
Clinical Trial Registration Number: NCT02867202 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study protocol 
 
The problem to be investigated 
Project title: A Randomized Clinical Trial to Assess the Efficacy 
of Intrauterine Balloon Compared to Intrauterine Contraceptive 
Device Plus Foley Catheter in the Therapy for Uterine Adhesion 
After Hysteroscopic Adhesiolysis. 
Research problem: This is a RCT designed to compare the 
efficacy of heart-shaped intrauterine balloon and Intrauterine 
Contraceptive Device Plus Foley Catheter in the prevention 
of adhesion reformation after hysteroscopic adhesiolysis. 
Background: The prevalence of IUAs varies from 0.2% in 
patients who undergo an intrauterine device insertion to 66.7% 
in patients with miscarriage curettage before. (Schenker & 
Margalioth, 1982) Hysteroscopic technique remain an accurate 
diagnosis for presence, degree of adhesions during the last two 
decades. (Fernandez, Al-Najjar, Chauveaud-Lambling, Frydman, 
& Gervaise, 2006)Hysteroscopic adhesiolysis currently become 
a safe and effective management to restore normal uterine cavity, 
however, the high incidence rate of postoperative adhesion 
reformation is a main challenge and difficult to solve, especially 
in patients with severe IUAs, in whom the recurrence rate was 

reported up to 62.5%. (Yu, Wong, Cheong, Xia, & Li, 
2008)Various adjunctive treatments have been proposed in an 
attempt to reduce postoperative recurrence. Despite the many 
proposed solutions, no particular method has proven to be the 
optima measure in preventing adhesion formation. Thereby, we 
put forward a new approach which combine intrauterine 
contraceptive device (IUD) with Foley catheter in the prevention 
of postoperative adhesion reformation, and there is as yet no 
study to confirm its value. 
The aims: The aim of our study was to evaluate the efficacy of 
IUD plus Foley catheter and intrauterine balloon after 
hysteroscopic adhesiolysis in patients with moderate to severe 
adhesion according to the American Fertility Society (AFS) 
classification of intrauterine adhesions. 
(v) The hypothesis: IUD plus Foley catheter presented a 
greater improvement in adhesion score than heart-shaped 
balloon in a retrospective study 
2. Methods of investigation: 
Subjects: The patients were totally recruited from the 1st 
affiliated hospital of Wenzhou Medical University between 
August 2016 and December 2017. 
Inclusion Criteria: 

1) women aged 18 to 45 years. 
2) patients had no history of hysteroscopic adhesiolysis. 
3) agreed to have second-look hysteroscopy. 
4) moderate to severe IUA (AFS score ≥5) according to 
American Fertility Society (AFS) scoring system. 
5) written informed consent obtained. 
Exclusion Criteria: 
1) minimal adhesion (AFS score <5) and 
2) previous hysteroscopic adhesiolysis. 
3) Inability or refusal to provide informed consent 
Design: Prospective, randomized, controlled trial. 
Experimental procedure: The heart-shaped intrauterine balloon 
is designed to fit into the cavity of the uterus, and removed on 
the 7th day after surgery. And hysteroscopy was taken out again 
after two menstrual cycles to evaluate the uterine adhesions. 
Intrauterine Contraceptive Device Plus Foley Catheter are 
inserted into the uterine after a hysteroscopic adhesiolysis. Foley 
Catheter is removed after three days while IUD removed at the 
second hysteroscopy. Uterine adhesions were judged again at the 
second hysteroscopy. The presence of adhesion was confirmed 
and uterine anatomy had been assessed at first-look and 
second-look hysteroscopy.