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

被引：27

作者：

van Rijswijk, Joukje ^{[1
]}

van Welie, Nienke ^{[1
]}

Dreyer, Kim ^{[1
]}

van Hooff, Machiel H. A. ^{[2
]}

de Bruin, Jan Peter ^{[3
]}

Verhoeve, Harold R. ^{[4
]}

Mol, Femke ^{[5
]}

Kleiman-Broeze, Kimiko A. ^{[6
]}

Traas, Maaike A. F. ^{[7
]}

Muijsers, Guido J. J. M. ^{[8
]}

Manger, Arentje P. ^{[9
]}

Gianotten, Judith ^{[10
]}

de Koning, Cornelia H. ^{[11
]}

Koning, AafkeM. H. ^{[12
]}

Bayram, Neriman ^{[13
]}

van der Ham, David P. ^{[14
]}

Vrouenraets, Francisca P. J. M. ^{[15
]}

Kalafusova, Michaela ^{[16
]}

van de Laar, Bob I. G. ^{[17
]}

Kaijser, Jeroen ^{[18
]}

van Oostwaard, Miriam F. ^{[19
]}

Meijer, Wouter J. ^{[20
]}

Broekmans, Frank J. M. ^{[21
]}

Valkenburg, Olivier ^{[22
]}

van der Voet, Lucy F. ^{[23
]}

van Disseldorp, Jeroen ^{[24
]}

Lambers, Marieke J. ^{[25
]}

Peters, Henrike E. ^{[1
]}

Lier, Marit C. I. ^{[1
]}

Lambalk, Cornelis B. ^{[1
]}

van Wely, Madelon ^{[26
]}

Bossuyt, Patrick M. M. ^{[26
]}

Stoker, Jaap ^{[27
]}

van der Veen, Fulco

Mol, Benw. J. ^{[28
,29
]}

Mijatovic, Velja ^{[1
]}

机构：

[1] Vrije Univ Amsterdam, Med Ctr, Dept Reprod Med, Postal Code 7057, NL-1007 MB Amsterdam, Netherlands

[2] Sint Franciscus Hosp, Dept Obstet & Gynaecol, Kleiweg 500, NL-3045 PM Rotterdam, Netherlands

[3] Jeroen Bosch Hosp, Dept Obstet & Gynaecol, Henri Dunantstr 1, NL-5223 GZ Den Bosch, Netherlands

[4] OLVG Oost, Dept Obstet & Gynaecol, Oosterpk 9, NL-1091 AC Amsterdam, Netherlands

[5] Acad Med Ctr, Dept Obstet & Gynaecol, Ctr Reprod Med, Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands

[6] Flevo Hosp, Dept Obstet & Gynaecol, Hosp Weg 1, NL-1315 RA Almere, Netherlands

[7] Gelre Hosp, Dept Obstet & Gynaecol, Albert Schweitzerlaan,31, NL-7334 DZ Apeldoorn, Netherlands

[8] Rivierenland Hosp, Dept Obstet & Gynaecol, President Kennedylaan 1, NL-4002 WP Tiel, Netherlands

[9] Diakonessen Hosp, Dept Obstet & Gynaecol, Bosboomstr 1, NL-3582 KE Utrecht, Netherlands

[10] Spaarne Gasthuis, Dept Obstet & Gynaecol, Boerhaavelaan 22, NL-2035 RC Haarlem, Netherlands

[11] Tergooi Hosp, Dept Obstet & Gynaecol, Rijksstraatweg 1, NL-1261 AN Blaricum, Netherlands

[12] Amstelland Hosp, Dept Obstet & Gynaecol, Laan Helende Meesters 8, NL-1186 AM Amstelveen, Netherlands

[13] Zaans Med Ctr, Dept Obstet & Gynaecol, Julianapl 58, NL-1502 DV Zaandam, Netherlands

[14] Martini Hosp Groningen, Dept Obstet & Gynaecol, Swietenpl 1, NL-9700 RB Groningen, Netherlands

[15] Zuyderland Med Ctr, Dept Obstet & Gynaecol, Henri Dunantstr 5, NL-6419 PC Heerlen, Netherlands

[16] Refaja Hosp, Dept Obstet & Gynaecol, Boerhaavestr 1, NL-9501 HE Stadskanaal, Netherlands

[17] OLVG, Dept Obstet & Gynaecol, West,Jan Tooropstr, NL-1061 AE Amsterdam, Netherlands

[18] Ikazia Med Ctr, Dept Obstet & Gynaecol, Montessoriweg 1, NL-3083 AN Rotterdam, Netherlands

[19] IJsselland Hosp, Dept Obstet & Gynaecol, Prins Constantijnweg 2, NL-2906 ZC Capelle aan den IJssel, Netherlands

[20] Gelre Hosp, Dept Obstet & Gynaecol, Elterweg 77, NL-7207 AE Zutphen, Netherlands

[21] Univ Med Ctr Utrecht, Dept Reprod Med & Gynaecol, Heidelberglaan 100, NL-3584 CX Utrecht, Netherlands

[22] Maastricht Univ, Med Ctr, Dept Reprod Med, P debeylaan,25, NL-6229 HX Maastricht, Netherlands

[23] Deventer Hosp, Dept Obstet & Gynaecol, Nico Bolkesteinlaan 75, NL-7416 SE Deventer, Netherlands

[24] St Antonius Hosp, Dept Obstet & Gynaecol, Koekoekslaan 1, NL-3435 CM Nieuwegein, Netherlands

[25] Westfriesgasthuis, Dept Obstet & Gynaecol, Maelsonstr 3, NL-1624 NP Hoorn, Netherlands

[26] Acad Med Ctr, Dept Epidemiol Biostat & Bioinformat, Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands

[27] Acad Med Ctr, Dept Radiol & Nucl Med, Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands

[28] Robinson Res Inst, Sch Paediat & Reprod Hlth, Adelaide, SA, Australia

[29] South Australian Hlth & Med Res Inst, Adelaide, SA, Australia

来源：

BMC WOMENS HEALTH | 2018年 / 18卷

关键词：

Hysterosalpingo foam sonography (HyFoSy); Hysterosalpingography (HSG); Fertility work-up; Tubal patency testing; Ongoing pregnancy; Cost effectiveness; Subfertility; Randomized controlled trial; Budget impact; HEALTH SURVEY; VALIDATION; SF-36;

D O I：

10.1186/s12905-018-0556-6

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

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.

引用

页数：7

共 15 条

[1] Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations [J].