油基或水基对比剂在不孕女性子宫输卵管造影中的应用。

Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women.

机构信息

From the Department of Reproductive Medicine (K.D., J.R., V.M., P.G.A.H.) and the Department of Epidemiology and Biostatistics (J.W.R.T.), VU University Medical Center, the Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Academic Medical Center (M.G.), the Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis (H.R.V.), and the Department of Obstetrics and Gynecology, Slotervaart Medical Center (A.E.J.D.), Amsterdam, and the Department of Obstetrics and Gynecology, TweeSteden Hospital (I.A.J.R.), and the Department of Obstetrics and Gynecology, Sint Elisabeth Hospital (J.M.J.S.), Tilburg, the Department of Reproductive Medicine and Gynecology, University of Groningen, University Medical Center Groningen, Groningen (A.H.), the Department of Obstetrics and Gynecology, VieCuri Medical Center, Venlo (P.B.), the Department of Obstetrics and Gynecology, Rijnstate Hospital, Arnhem (A.W.N.), the Department of Obstetrics and Gynecology, Albert Schweitzer Hospital, Dordrecht (H.G.M.R.-L.), the Department of Obstetrics and Gynecology, Bravis Hospital, Roosendaal (C.C.M.T.), the Department of Obstetrics and Gynecology, Röpcke-Zweers Hospital, Hardenberg (M.K.), the Department of Obstetrics and Gynecology, Zaans Medical Center, Zaandam (A.B.H.), the Department of Obstetrics and Gynecology, Elkerliek Hospital, Helmond (A.P.G.), the Department of Reproductive Medicine, Maastricht University Medical Center, Maastricht (R.G.), the Department of Obstetrics and Gynecology, Canisius-Wilhelmina Hospital, Nijmegen (C.F.H.), the Department of Obstetrics and Gynecology, Wilhelmina Hospital, Assen (A.V.S.), the Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, Den Bosch (J.-P.B.), the Department of Obstetrics and Gynecology, Westfriesgasthuis, Hoorn (J.A.M.B.), the Department of Obstetrics and Gynecology, Hospital Gelderse Vallei, Ede (E.S.), the Department of Obstetrics and Gynecology, Amstelland Hospital, Amstelveen (A.M.), the Department of Obstetrics and Gynecology, Scheper Hospital, Emmen (M.J.P.), the Department of Obstetrics and Gynecology, Gelre Hospital, Apeldoorn (M.A.F.T.), the Department of Obstetrics and Gynecology, Sint Franciscus Hospital, Rotterdam (M.H.A.H.), the Department of Obstetrics and Gynecology, Diaconessenhuis (G.A.U.), and the Department of Medical Statistics and Bioinformatics, Leiden University Medical Center (N.G.), Leiden, and the Department of Obstetrics and Gynecology, Tergooi Hospital, Blaricum (C.H.K.) - all in the Netherlands; and the School of Medicine, Robinson Research Institute, University of Adelaide, and the South Australian Health and Medical Research Institute, Adelaide, SA, Australia (B.W.J.M.).

出版信息

N Engl J Med. 2017 May 25;376(21):2043-2052. doi: 10.1056/NEJMoa1612337. Epub 2017 May 18.

DOI:10.1056/NEJMoa1612337

PMID:28520519

Abstract

BACKGROUND

Pregnancy rates among infertile women have been reported to increase after hysterosalpingography, but it is unclear whether the type of contrast medium used (oil-based or water-soluble contrast) influences this potential therapeutic effect.

METHODS

We performed a multicenter, randomized trial in 27 hospitals in the Netherlands in which infertile women who were undergoing hysterosalpingography were randomly assigned to undergo this procedure with the use of oil-based or water-based contrast. Subsequently, couples received expectant management or the women underwent intrauterine insemination. The primary outcome was ongoing pregnancy within 6 months after randomization. Outcomes were analyzed according to the intention-to-treat principle.

RESULTS

A total of 1119 women were randomly assigned to hysterosalpingography with oil contrast (557 women) or water contrast (562 women). A total of 220 of 554 women in the oil group (39.7%) and 161 of 554 women in the water group (29.1%) had an ongoing pregnancy (rate ratio, 1.37; 95% confidence interval [CI], 1.16 to 1.61; P<0.001), and 214 of 552 women in the oil group (38.8%) and 155 of 552 women in the water group (28.1%) had live births (rate ratio, 1.38; 95% CI, 1.17 to 1.64; P<0.001). Rates of adverse events were low and similar in the two groups.

CONCLUSIONS

Rates of ongoing pregnancy and live births were higher among women who underwent hysterosalpingography with oil contrast than among women who underwent this procedure with water contrast. (Netherlands Trial Register number, NTR3270 .).

摘要

背景

有报道称，子宫输卵管造影后不孕妇女的妊娠率有所提高，但使用的造影剂类型（油基或水溶性）是否会影响这种潜在的治疗效果尚不清楚。

方法

我们在荷兰的 27 家医院进行了一项多中心、随机试验，将接受子宫输卵管造影的不孕妇女随机分为油基或水基造影组。随后，夫妇接受期待治疗或女性接受宫腔内人工授精。主要结局是随机分组后 6 个月内的持续妊娠。根据意向治疗原则分析结局。

结果

共有 1119 名妇女被随机分配接受油基造影（557 名妇女）或水基造影（562 名妇女）。油组 554 名妇女中有 220 名（39.7%），水组 554 名妇女中有 161 名（29.1%）发生持续妊娠（率比，1.37；95%置信区间[CI]，1.16 至 1.61；P<0.001），油组 552 名妇女中有 214 名（38.8%），水组 552 名妇女中有 155 名（28.1%）发生活产（率比，1.38；95%CI，1.17 至 1.64；P<0.001）。两组不良事件发生率低且相似。