The FOAM study: is Hysterosalpingo foam sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women? Study protocol for a randomized controlled trial.

Autor: van Rijswijk J; Department of Reproductive Medicine, VU University Medical Centre, Postal code, 7057 1007, MB, Amsterdam, The Netherlands. j.vanrijswijk@vumc.nl., van Welie N; Department of Reproductive Medicine, VU University Medical Centre, Postal code, 7057 1007, MB, Amsterdam, The Netherlands., Dreyer K; Department of Reproductive Medicine, VU University Medical Centre, Postal code, 7057 1007, MB, Amsterdam, The Netherlands., van Hooff MHA; Department of Obstetrics and Gynaecology, Sint Franciscus Hospital, Kleiweg 500, 3045PM, Rotterdam, The Netherlands., de Bruin JP; Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223, GZ, Den Bosch, The Netherlands., Verhoeve HR; Department of Obstetrics and Gynaecology, OLVG Oost, Oosterpark 9, 1091, AC, Amsterdam, The Netherlands., Mol F; Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam, the Netherlands., Kleiman-Broeze KA; Department of Obstetrics and Gynaecology, Flevo Hospital, Hospitaalweg 1, 1315, RA, Almere, The Netherlands., Traas MAF; Department of Obstetrics and Gynaecology, Gelre Hospital, Albert Schweitzerlaan, 31 7334, DZ, Apeldoorn, The Netherlands., Muijsers GJJM; Department of Obstetrics and Gynaecology, Rivierenland Hospital, President Kennedylaan 1, 4002, WP, Tiel, The Netherlands., Manger AP; Department of Obstetrics and Gynaecology, Diakonessenhuis, Bosboomstraat 1, 3582, KE, Utrecht, The Netherlands., Gianotten J; Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Boerhaavelaan 22, 2035RC, Haarlem, The Netherlands., de Koning CH; Department of Obstetrics and Gynaecology, Tergooi Hospital, Rijksstraatweg 1 1261 AN, Blaricum, The Netherlands., Koning AMH; Department of Obstetrics and Gynaecology, Amstelland Hospital, Laan van de Helende Meesters 8, 1186, AM, Amstelveen, The Netherlands., Bayram N; Department of Obstetrics and Gynaecology, Zaans Medical Centre, Kon, Julianaplein 58, 1502 DV Zaandam, Zaandam, The Netherlands., van der Ham DP; Department of Obstetrics and Gynaecology, Martini Hospital Groningen, Van Swietenplein 1, 9700, Groningen, RB, Netherlands., Vrouenraets FPJM; Department of Obstetrics and Gynecology, Zuyderland Medical Center, Henri Dunantstraat 5, 6419, PC, Heerlen, The Netherlands., Kalafusova M; Department of Obstetrics and Gynaecology, Refaja Hospital, Boerhaavestraat 1, 9501, HE, Stadskanaal, The Netherlands., van de Laar BIG; Department of Obstetrics and Gynaecology, OLVG West, Jan Tooropstraat, 164 1061AE, Amsterdam, The Netherlands., Kaijser J; JDepartment of Obstetrics and Gynaecology, Ikazia medical center, Montessoriweg 1, 3083, AN, Rotterdam, The Netherlands., van Oostwaard MF; Department of Obstetrics and Gynaecology, IJsselland hospital, Prins Constantijnweg 2, 2906, ZC, Capelle a/d Ijssel, The Netherlands., Meijer WJ; Department of Obstetrics and Gynaecology, Gelre Hospital, Den Elterweg 77, 7207AE, Zutphen, The Netherlands., Broekmans FJM; Department of Reproductive Medicine and Gynaecology, University Medical Centre Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands., Valkenburg O; Department of Reproductive Medicine, Maastricht University Medical Centre, P. debeylaan, 25 6229HX, Maastricht, The Netherlands., van der Voet LF; Department of Obstetrics and Gynaecology, Deventer Hospital, Nico Bolkesteinlaan 75, 7416, SE, Deventer, The Netherlands., van Disseldorp J; Department of Obstetrics and Gynaecology, Sint Antonius Hospital, Koekoekslaan 1, 3435, CM, Nieuwegein, The Netherlands., Lambers MJ; Department of Obstetrics and Gynaecology, Westfriesgasthuis, Maelsonstraat 3, 1624, NP, Hoorn, The Netherlands., Peters HE; Department of Reproductive Medicine, VU University Medical Centre, Postal code, 7057 1007, MB, Amsterdam, The Netherlands., Lier MCI; Department of Reproductive Medicine, VU University Medical Centre, Postal code, 7057 1007, MB, Amsterdam, The Netherlands., Lambalk CB; Department of Reproductive Medicine, VU University Medical Centre, Postal code, 7057 1007, MB, Amsterdam, The Netherlands., van Wely M; Department of Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands., Bossuyt PMM; Department of Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands., Stoker J; Department of Radiology and Nuclear Medicine, Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands., van der Veen F; Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam, the Netherlands., Mol BWJ; School of Paediatrics and Reproductive Health, The Robinson Research Institute and The South Australian Health and Medical Research Institute, Adelaide, Australia., Mijatovic V; Department of Reproductive Medicine, VU University Medical Centre, Postal code, 7057 1007, MB, Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: BMC women's health [BMC Womens Health] 2018 May 09; Vol. 18 (1), pp. 64. Date of Electronic Publication: 2018 May 09.
DOI: 10.1186/s12905-018-0556-6
Abstrakt: Background: Tubal pathology is a causative factor in 20% of subfertile couples. Traditionally, tubal testing during fertility work-up is performed by hysterosalpingography (HSG). Hysterosalpingo-foam sonography (HyFoSy) is a new technique that is thought to have comparable accuracy as HSG, while it is less expensive and more patient friendly. HyFoSy would be an acceptable alternative for HSG, provided it has similar effectiveness in terms of patient outcomes.
Methods/design: We aim to compare the effectiveness and costs of management guided by HyFoSy or by HSG. Consenting women will undergo tubal testing by both HyFoSy and HSG in a randomized order during fertility work-up. The study group will consist of 1163 subfertile women between 18 and 41 years old who are scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male subfertility or a known contrast (iodine) allergy will be excluded. We anticipate that 7 % (N = 82) of the participants will have discordant test results for HyFoSy and HSG. These participants will be randomly allocated to either a management strategy based on HyFoSy or a management strategy based on HSG, resulting in either a diagnostic laparoscopy with chromopertubation or a strategy that assumes tubal patency (intrauterine insemination or expectant management). The primary outcome is ongoing pregnancy leading to live birth within 12 months after randomization. Secondary outcomes are patient pain scores, time to pregnancy, clinical pregnancy, miscarriage rate, multiple pregnancy rate, preterm birth rate and number of additional treatments. Costs will be estimated by counting resource use and calculating unit prices.
Discussion: This trial will compare the effectiveness and costs of HyFoSy versus HSG in assessing tubal patency in subfertile women.
Trial Registration: Dutch Trial Register (NTR 4746, http://www.trialregister.nl ). Date of registration: 19 August 2014.
Databáze: MEDLINE
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