Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
OBJECTIVE
To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device (IUD) in the prevention of adhesion reformation after hysteroscopic adhesiolysis.


METHODS
Prospective, randomized, controlled trial.


METHODS
University hospital.


METHODS
A total of 201 women with Asherman syndrome.


METHODS
Women were randomized to having either a heart-shaped intrauterine balloon or an IUD fitted after hysteroscopic adhesiolysis. The devices were removed after 7 days. A second-look hysteroscopy was carried out 1 to 2 months after the surgery.


METHODS
Incidence of adhesion reformation and reduction of adhesion score before and after surgery.


RESULTS
Initially 201 cases were recruited; 39 cases dropped out, resulting in 82 cases in the balloon group and 80 cases in IUD group. The age, menstrual characteristics, pregnancy history, and American Fertility Society score before surgery were comparable between the two groups. The median adhesion score reduction (balloon group, 7; IUD group, 7) and the adhesion reformation rate (balloon group, 30%; IUD group, 35%) were not significantly different between the two groups.


CONCLUSIONS
The heart-shaped intrauterine balloon and IUD are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome.


BACKGROUND
ISRCTN 69690272.
Center for Reproductive Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, People's Republic of China.
Xiao-Na
XN
Lin
Center for Reproductive Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, People's Republic of China.
Feng
F
Zhou
Center for Reproductive Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, People's Republic of China.
Min-Ling
ML
Wei
Center for Reproductive Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, People's Republic of China.
Yang
Y
Yang
Center for Reproductive Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, People's Republic of China.
Ying
Y
Li
Department of Reproductive Medicine, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, People's Republic of China.
T C
TC
Li
Center for Reproductive Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, People's Republic of China. Electronic address: zhangsongying@126.com.
Song-Ying
SY
Zhang
D000328:Adult; D005260:Female; D006175:Gynatresia / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects / Q000639:trends*; D007434:Intrauterine Devices; D011183:Postoperative Complications / Q000175:diagnosis / Q000517:prevention & control*; D011446:Prospective Studies; D011474:Prosthesis Design / Q000592:standards; D000267:Tissue Adhesions / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome; D014591:Uterine Diseases / Q000175:diagnosis / Q000601:surgery
Asherman syndrome; hysteroscopy; intrauterine balloon; intrauterine contraceptive device