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

Joukje van Rijswijk, Nienke van Welie, Kim Dreyer, Machiel H. A. van Hooff, Jan Peter de Bruin, Harold R. Verhoeve, Femke Mol, Kimiko A. Kleiman-Broeze, Maaike A. F. Traas, Guido J. J. M. Muijsers, Arentje P. Manger, Judith Gianotten, Cornelia H. de Koning, Aafke M. H. Koning, Neriman Bayram, David P. van der Ham, Francisca P. J. M. Vrouenraets, Michaela Kalafusova, Bob I. G. van de Laar, Jeroen Kaijser & 16 others Miriam F. van Oostwaard, Wouter J. Meijer, Frank J. M. Broekmans, Olivier Valkenburg, Lucy F. van der Voet, Jeroen van Disseldorp, Marieke J. Lambers, Henrike E. Peters, Marit C. I. Lier, Cornelis B. Lambalk, Madelon van Wely, Patrick M. M. Bossuyt, Jaap Stoker, Fulco van der Veen, Ben W. J. Mol, Velja Mijatovic

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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 41years 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 12months 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.
Original languageEnglish
Article number64
JournalBMC Women's Health
Volume18
Issue number1
DOIs
Publication statusPublished - 2018

Cite this

van Rijswijk, Joukje ; van Welie, Nienke ; Dreyer, Kim ; van Hooff, Machiel H. A. ; de Bruin, Jan Peter ; Verhoeve, Harold R. ; Mol, Femke ; Kleiman-Broeze, Kimiko A. ; Traas, Maaike A. F. ; Muijsers, Guido J. J. M. ; Manger, Arentje P. ; Gianotten, Judith ; de Koning, Cornelia H. ; Koning, Aafke M. H. ; Bayram, Neriman ; van der Ham, David P. ; Vrouenraets, Francisca P. J. M. ; Kalafusova, Michaela ; van de Laar, Bob I. G. ; Kaijser, Jeroen ; van Oostwaard, Miriam F. ; Meijer, Wouter J. ; Broekmans, Frank J. M. ; Valkenburg, Olivier ; van der Voet, Lucy F. ; van Disseldorp, Jeroen ; Lambers, Marieke J. ; Peters, Henrike E. ; Lier, Marit C. I. ; Lambalk, Cornelis B. ; van Wely, Madelon ; Bossuyt, Patrick M. M. ; Stoker, Jaap ; van der Veen, Fulco ; Mol, Ben W. J. ; Mijatovic, Velja. / 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. In: BMC Women's Health. 2018 ; Vol. 18, No. 1.
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title = "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",
abstract = "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 41years 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 12months 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.",
author = "{van Rijswijk}, Joukje and {van Welie}, Nienke and Kim Dreyer and {van Hooff}, {Machiel H. A.} and {de Bruin}, {Jan Peter} and Verhoeve, {Harold R.} and Femke Mol and Kleiman-Broeze, {Kimiko A.} and Traas, {Maaike A. F.} and Muijsers, {Guido J. J. M.} and Manger, {Arentje P.} and Judith Gianotten and {de Koning}, {Cornelia H.} and Koning, {Aafke M. H.} and Neriman Bayram and {van der Ham}, {David P.} and Vrouenraets, {Francisca P. J. M.} and Michaela Kalafusova and {van de Laar}, {Bob I. G.} and Jeroen Kaijser and {van Oostwaard}, {Miriam F.} and Meijer, {Wouter J.} and Broekmans, {Frank J. M.} and Olivier Valkenburg and {van der Voet}, {Lucy F.} and {van Disseldorp}, Jeroen and Lambers, {Marieke J.} and Peters, {Henrike E.} and Lier, {Marit C. I.} and Lambalk, {Cornelis B.} and {van Wely}, Madelon and Bossuyt, {Patrick M. M.} and Jaap Stoker and {van der Veen}, Fulco and Mol, {Ben W. J.} and Velja Mijatovic",
year = "2018",
doi = "10.1186/s12905-018-0556-6",
language = "English",
volume = "18",
journal = "BMC Women's Health",
issn = "1472-6874",
publisher = "BioMed Central",
number = "1",

}

van Rijswijk, J, van Welie, N, Dreyer, K, van Hooff, MHA, de Bruin, JP, Verhoeve, HR, Mol, F, Kleiman-Broeze, KA, Traas, MAF, Muijsers, GJJM, Manger, AP, Gianotten, J, de Koning, CH, Koning, AMH, Bayram, N, van der Ham, DP, Vrouenraets, FPJM, Kalafusova, M, van de Laar, BIG, Kaijser, J, van Oostwaard, MF, Meijer, WJ, Broekmans, FJM, Valkenburg, O, van der Voet, LF, van Disseldorp, J, Lambers, MJ, Peters, HE, Lier, MCI, Lambalk, CB, van Wely, M, Bossuyt, PMM, Stoker, J, van der Veen, F, Mol, BWJ & Mijatovic, V 2018, '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' BMC Women's Health, vol. 18, no. 1, 64. https://doi.org/10.1186/s12905-018-0556-6

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. / van Rijswijk, Joukje; van Welie, Nienke; Dreyer, Kim; van Hooff, Machiel H. A.; de Bruin, Jan Peter; Verhoeve, Harold R.; Mol, Femke; Kleiman-Broeze, Kimiko A.; Traas, Maaike A. F.; Muijsers, Guido J. J. M.; Manger, Arentje P.; Gianotten, Judith; de Koning, Cornelia H.; Koning, Aafke M. H.; Bayram, Neriman; van der Ham, David P.; Vrouenraets, Francisca P. J. M.; Kalafusova, Michaela; van de Laar, Bob I. G.; Kaijser, Jeroen; van Oostwaard, Miriam F.; Meijer, Wouter J.; Broekmans, Frank J. M.; Valkenburg, Olivier; van der Voet, Lucy F.; van Disseldorp, Jeroen; Lambers, Marieke J.; Peters, Henrike E.; Lier, Marit C. I.; Lambalk, Cornelis B.; van Wely, Madelon; Bossuyt, Patrick M. M.; Stoker, Jaap; van der Veen, Fulco; Mol, Ben W. J.; Mijatovic, Velja.

In: BMC Women's Health, Vol. 18, No. 1, 64, 2018.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - van Rijswijk, Joukje

AU - van Welie, Nienke

AU - Dreyer, Kim

AU - van Hooff, Machiel H. A.

AU - de Bruin, Jan Peter

AU - Verhoeve, Harold R.

AU - Mol, Femke

AU - Kleiman-Broeze, Kimiko A.

AU - Traas, Maaike A. F.

AU - Muijsers, Guido J. J. M.

AU - Manger, Arentje P.

AU - Gianotten, Judith

AU - de Koning, Cornelia H.

AU - Koning, Aafke M. H.

AU - Bayram, Neriman

AU - van der Ham, David P.

AU - Vrouenraets, Francisca P. J. M.

AU - Kalafusova, Michaela

AU - van de Laar, Bob I. G.

AU - Kaijser, Jeroen

AU - van Oostwaard, Miriam F.

AU - Meijer, Wouter J.

AU - Broekmans, Frank J. M.

AU - Valkenburg, Olivier

AU - van der Voet, Lucy F.

AU - van Disseldorp, Jeroen

AU - Lambers, Marieke J.

AU - Peters, Henrike E.

AU - Lier, Marit C. I.

AU - Lambalk, Cornelis B.

AU - van Wely, Madelon

AU - Bossuyt, Patrick M. M.

AU - Stoker, Jaap

AU - van der Veen, Fulco

AU - Mol, Ben W. J.

AU - Mijatovic, Velja

PY - 2018

Y1 - 2018

N2 - 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 41years 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 12months 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.

AB - 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 41years 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 12months 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.

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85046627933&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/29743106

U2 - 10.1186/s12905-018-0556-6

DO - 10.1186/s12905-018-0556-6

M3 - Article

VL - 18

JO - BMC Women's Health

JF - BMC Women's Health

SN - 1472-6874

IS - 1

M1 - 64

ER -