目的:评价宫腔球囊和宫内节育器对中重度宫腔粘连不孕患者宫腔镜下粘连松解术后粘连重建的预防效果及妊娠结局。
方法:前瞻性,随机化,对照试验研究。
方法:某三级大学医院。
方法:共纳入130例中度(美国生育学会[AFS]评分5-8分)和重度(AFS评分9-12分)宫腔粘连患者。
方法:将86例患者平均分为使用IUD治疗1个月的组和使用IUD治疗2个月的组。44名患者被分配到使用Foley导管球囊治疗的组。(宫内节育器:元宫宫内节育器)。
结果:主要结局指标是AFS评分,子宫内膜厚度,和妊娠结局。宫腔镜检查后,AFS评分明显下降(P<0.05),而子宫内膜厚度在三组间显著增加(P<0.001).值得注意的是,球囊组AFS评分下降幅度大于IUD-1个月组和IUD-2个月组(P<0.01),IUD组之间无显著差异(P=0.298)。最后,此外,3组子宫内膜厚度增加程度(P=0.502)和妊娠结局(P=0.803)无显著差异。
结论:插入球囊或放置宫内节育器一两个月可以有效降低粘连复发的风险,并恢复子宫腔的形状。虽然球囊的治疗效果优于宫内节育器,1个月和2个月IUD组无显著差异.
背景:这项研究已在中国临床试验注册中心注册(http://www.chictr.org.cn/enIndex。aspx);临床试验注册标识号:ChiCTR-IOR-17,011,943(http://www.chictr.org.cn/showprojen.aspx?proj=17979)。试用登记日期:2017年7月11日。
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.
METHODS: A prospective, randomized, controlled trial study.
METHODS: A tertiary university hospital.
METHODS: 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.
METHODS: 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).
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.
CONCLUSIONS: 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.
BACKGROUND: 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.