Liang Guiling, Zhu Qian, He Xiaoqing, Wang Xiaofeng, Jiang Ling, Zhu Chenfeng, Xie Li, Qian Zhaoxia, Zhang Jian
Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Shanghai Key Laboratory Embryo Original Diseases, Shanghai, China.
BMJ Open. 2020 Oct 27;10(10):e039166. doi: 10.1136/bmjopen-2020-039166.
In recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age. Hysterosalpingography (HSG) is a common diagnostic procedure during fertility examinations. However, there is no consensus on the choice of contrast agents and their effects. As the largest multicentre, randomised controlled trial (H2Oil trial from the Netherlands) has shown that oil-soluble contrast at HSG can enhance fertility compared with water-soluble contrast, we propose this study to examine whether the use of oil-soluble contrast media results in increased rates of pregnancy in Chinese women undergoing HSG.
This study is a single-centre, randomised, controlled, parallel-group, superiority trial. Patients with low risk of tubal disease will be randomised to undergo HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media). To evaluate the potential superiority of the OSCM group, with 1:1 allocation ratio, 90% statistical power and a two-sided significance level of 5%, we have calculated a sample of 520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation. The primary outcome is the rate of ongoing pregnancy during 6 months after randomisation. The secondary outcomes will consist of thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations of the OSCM group/WSCM group, and assisted reproductive technology treatments between the two groups.
This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 18 January 2020 (approval no GKLW2020-02). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.
ChiCTR2000031612.
近年来，由于各种因素，中国的不孕不育率有所上升，目前影响着超过10%的育龄妇女。子宫输卵管造影术（HSG）是生育检查中的一种常见诊断程序。然而，关于造影剂的选择及其效果尚无共识。由于荷兰最大的多中心随机对照试验（H2Oil试验）表明，HSG时使用油溶性造影剂与水溶性造影剂相比可提高受孕几率，我们开展本研究以探讨在中国接受HSG的女性中使用油溶性造影剂是否会提高妊娠率。
本研究是一项单中心、随机、对照、平行组、优效性试验。输卵管疾病低风险患者将被随机分为两组，分别接受碘化油注射行HSG（OSCM组，油溶性造影剂）或碘海醇注射（WSCM组，水溶性造影剂）。为评估OSCM组的潜在优效性，按照1:1分配比例、90%的检验效能和5%的双侧显著性水平，我们计算得出每组需纳入520名女性，共计1040名，其中包括10%的失访或方案偏离。主要结局是随机分组后6个月内的持续妊娠率。次要结局将包括患者及新生儿的甲状腺功能、HSG期间的疼痛评分、活产率、临床妊娠率、流产率、异位妊娠率、持续妊娠时间、活产时间、OSCM组/WSCM组的成本计算以及两组间的辅助生殖技术治疗情况。
本方案于2020年1月18日获得国际和平妇幼保健院医学研究伦理委员会的批准（批准号GKLW2020 - 02）。研究结果将在同行评审的出版物以及国际科学会议的报告中公布。
ChiCTR2000031612
