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Randomized Controlled Trial Multicenter Study Comparative Study
Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women.
- Kim Dreyer, Joukje van Rijswijk, Velja Mijatovic, Mariëtte Goddijn, Harold R Verhoeve, Ilse A J van Rooij, Annemieke Hoek, Petra Bourdrez, Annemiek W Nap, Henrike G M Rijnsaardt-Lukassen, Catharina C M Timmerman, Mesrure Kaplan, Angelo B Hooker, Anna P Gijsen, Ron van Golde, Cathelijne F van Heteren, Alexander V Sluijmer, Jan-Peter de Bruin, Jesper M J Smeenk, Jacoba A M de Boer, Eduard Scheenjes, Annette E J Duijn, Alexander Mozes, Marie J Pelinck, Maaike A F Traas, Machiel H A van Hooff, Gijsbertus A van Unnik, Cornelia H de Koning, Nan van Geloven, Jos W R Twisk, Peter G A Hompes, and Ben W J Mol.
- 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.).
- N. Engl. J. Med. 2017 May 25; 376 (21): 2043-2052.
BackgroundPregnancy 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.MethodsWe 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.ResultsA 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.ConclusionsRates 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 .).
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