Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis

Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30.

Abstract

Objective: To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device (IUD) in the prevention of adhesion reformation after hysteroscopic adhesiolysis.

Design: Prospective, randomized, controlled trial.

Setting: University hospital.

Patient(s): A total of 201 women with Asherman syndrome.

Intervention(s): 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.

Main outcome measure(s): Incidence of adhesion reformation and reduction of adhesion score before and after surgery.

Result(s): 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.

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

Clinical trial registration number: ISRCTN 69690272.

Keywords: Asherman syndrome; hysteroscopy; intrauterine balloon; intrauterine contraceptive device.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Gynatresia / diagnosis
  • Gynatresia / surgery*
  • Humans
  • Hysteroscopy / adverse effects
  • Hysteroscopy / trends*
  • Intrauterine Devices*
  • Postoperative Complications / diagnosis
  • Postoperative Complications / prevention & control*
  • Prospective Studies
  • Prosthesis Design / standards
  • Tissue Adhesions / diagnosis
  • Tissue Adhesions / etiology
  • Tissue Adhesions / prevention & control
  • Treatment Outcome
  • Uterine Diseases / diagnosis
  • Uterine Diseases / surgery

Associated data

  • ISRCTN/ISRCTN69690272