Journal Article

Comparing the efficacy and pregnancy outcome of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis in infertile women: a prospective, randomized, controlled trial study

Zhang, Honghong, Ding, HaiXia, Qiao, Rui, Pang, Wenjuan, Sun, Ningxia, Ji, Yixuan, Li, Wen, Zhang, Qing

2024

Overview

Study objective To evaluate the efficacy and pregnancy outcomes of intrauterine balloon and intrauterine contraceptive devices in the prevention of adhesion reformation following hysteroscopic adhesiolysis in infertile women with moderate to severe intrauterine adhesion. Design A prospective, randomized, controlled trial study. Setting A tertiary university hospital. Patients A total of 130 patients with moderate (American Fertility Society [AFS] score of 5–8) and severe (AFS score of 9–12) intrauterine adhesions were recruited. Interventions 86 patients were evenly allocated to group treated with an IUD for 1 month and group treated with an IUD for 2 months. 44 patients were allocated to group treated with a Foley catheter balloon.(IUD: Yuangong IUD). Measurements and main results The primary outcome measures were the AFS score, endometrial thickness, and pregnancy outcome. After hysteroscopy, the AFS score was significantly decreased( P <0.05), whereas endometrial thickness was significantly increased across the three groups( P <0.001). Notably, the decline in the AFS score in the balloon group was greater than that in the IUD-1-month group and IUD-2-month group( P <0.01), with no significant difference between the IUD groups( P  = 0.298). Lastly, In addition, the extent of the increase in endometrial thickness( P  = 0.502) and the pregnancy outcomes( P  = 0.803) in the three groups were not significantly different. Conclusion Inserting a balloon or placing an IUD for one or two months can effectively lower the risk of adhesion recurrence and restore the shape of the uterine cavity. While the therapeutic effect of the balloon was superior to that of the IUD, no significant differences were observed in the one-month and two-month IUD groups. Trial registration This research was registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/enIndex.aspx ); Clinical trial registry identification number: ChiCTR-IOR-17,011,943 ( http://www.chictr.org.cn/showprojen.aspx?proj=17979 ). Date of trial registration: July 11, 2017.

• Publisher: BioMed Central,BioMed Central Ltd,BMC
• Subject: Adult / Care and treatment / Contraceptives / Diagnosis / Endocrinology / Female / Health aspects / Humans / Hysteroscopy / Hysteroscopy - methods / Infertility, Female - etiology / Infertility, Female - prevention & control / Infertility, Female - therapy / Intrauterine adhesion / Intrauterine balloon / Intrauterine contraceptive device / Intrauterine Devices / Medicine / Medicine & Public Health / Pregnancy / Pregnancy Outcome / Pregnancy Rate / Pregnant women / Prospective Studies / Reproductive Medicine / Risk factors / Tissue Adhesions - prevention & control / Treatment Outcome / Uterine diseases / Uterine Diseases - complications / Uterine Diseases - pathology / Uterine Diseases - prevention & control / Uterine Diseases - surgery