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; 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

doi: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

Joukje van Rijswijk^* (Corresponding Author), 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 KaijserMiriam 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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

21 Citations (Scopus)

3 Downloads (Pure)

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 language	English
Article number	64
Pages (from-to)	1-7
Number of pages	7
Journal	BMC Women's Health
Volume	18
Early online date	9 May 2018
DOIs	https://doi.org/10.1186/s12905-018-0556-6
Publication status	Published - 9 May 2018

Bibliographical note

This is an investigator initiated trial, VU medical center Amsterdam is the sponsor, contact information: prof. CJM de Groot, Department of Obstetrics and Gynaecology, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands, Tel: + 31-204444444. This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 837001504. ZonMW gives financial support for the whole project. IQ Medical Ventures provides the ExEm FOAM® kits. The funding bodies have no role in the design of the study; collection, analysis, and interpretation of data; and in writing the manuscript.

Data Availability Statement

Availability of data and materials
Data entry and secure storage is performed with data management system OpenClinica (OpenClinica LLC and collaborators, by TraIT (Translational Research IT infrastructure), version: 3.6). In each of the participating center, data entry according to Good Clinical Practice (GCP) was performed by dedicated research nurses, fertility doctors or gynecologists. Data control during the trial is possible. Monitoring will be performed in compliance with GCP and other rules and regulations in order to achieve high quality research and secure patient safety. Qualified and independent monitors from the NVOG Consortium will have access to the data and source documents of the trial. Based on the Site Specific Monitoring program of the NVOG Consortium, site evaluation visits will be performed to review the quality of the participating sites. For more detailed information see: NVOG Consortium 2.0, site specifiek evaluatie-en monitorplan, versie 2.0 (K6).The quality advisor will also perform data verification at the end of the trial. JvR, NvW, KD and VM will have access to the final dataset.

Keywords

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

Access to Document

10.1186/s12905-018-0556-6Licence: CC BY

Rijswijk_etal_BMCWH_The_FOAM_Study_VoRFinal published version, 800 KBLicence: CC BY

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this

van Rijswijk, J., van Welie, N., Dreyer, K., van Hooff, M. H. A., de Bruin, J. P., Verhoeve, H. R., Mol, F., Kleiman-Broeze, K. A., Traas, M. A. F., Muijsers, G. J. J. M., Manger, A. P., Gianotten, J., de Koning, C. H., Koning, A. M. H., Bayram, N., van der Ham, D. P., Vrouenraets, F. P. J. M., Kalafusova, M., van de Laar, B. I. G., ... 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, 18, 1-7. Article 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 (Corresponding Author); van Welie, Nienke; Dreyer, Kim et al.
In: BMC Women's Health, Vol. 18, 64, 09.05.2018, p. 1-7.

Research output: Contribution to journal › Article › peer-review

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, 64, pp. 1-7. https://doi.org/10.1186/s12905-018-0556-6

van Rijswijk J, van Welie N, Dreyer K, van Hooff MHA, de Bruin JP, Verhoeve HR et al. 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. 2018 May 9;18:1-7. 64. Epub 2018 May 9. doi: 10.1186/s12905-018-0556-6

@article{7526c1eba8e14d38aaac1b76962d5673,

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.",

keywords = "Budget impact, Cost-effectiveness, Fertility work-up, Hysterosalpingo foam sonography (HyFoSy), Hysterosalpingography (HSG), Ongoing pregnancy, Randomized controlled trial, Subfertility, Tubal patency testing",

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",

note = "This is an investigator initiated trial, VU medical center Amsterdam is the sponsor, contact information: prof. CJM de Groot, Department of Obstetrics and Gynaecology, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands, Tel: + 31-204444444. This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 837001504. ZonMW gives financial support for the whole project. IQ Medical Ventures provides the ExEm FOAM{\textregistered} kits. The funding bodies have no role in the design of the study; collection, analysis, and interpretation of data; and in writing the manuscript.",

year = "2018",

month = may,

day = "9",

doi = "10.1186/s12905-018-0556-6",

language = "English",

volume = "18",

pages = "1--7",

journal = "BMC Women's Health",

issn = "1472-6874",

publisher = "BioMed Central",

}

TY - JOUR

T1 - The FOAM study

T2 - 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

N1 - This is an investigator initiated trial, VU medical center Amsterdam is the sponsor, contact information: prof. CJM de Groot, Department of Obstetrics and Gynaecology, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands, Tel: + 31-204444444. This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 837001504. ZonMW gives financial support for the whole project. IQ Medical Ventures provides the ExEm FOAM® kits. The funding bodies have no role in the design of the study; collection, analysis, and interpretation of data; and in writing the manuscript.

PY - 2018/5/9

Y1 - 2018/5/9

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.

KW - Budget impact

KW - Cost-effectiveness

KW - Fertility work-up

KW - Hysterosalpingo foam sonography (HyFoSy)

KW - Hysterosalpingography (HSG)

KW - Ongoing pregnancy

KW - Randomized controlled trial

KW - Subfertility

KW - Tubal patency testing

UR - http://www.scopus.com/inward/record.url?scp=85046627933&partnerID=8YFLogxK

U2 - 10.1186/s12905-018-0556-6

DO - 10.1186/s12905-018-0556-6

M3 - Article

C2 - 29743106

AN - SCOPUS:85046627933

SN - 1472-6874

VL - 18

SP - 1

EP - 7

JO - BMC Women's Health

JF - BMC Women's Health

M1 - 64

ER -

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

Bibliographical note

Data Availability Statement

Keywords

Access to Document

Other files and links

Fingerprint

Cite this