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. 2018 May 9;18(1):64.
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  1 , Nienke van Welie  2 , Kim Dreyer  2 , Machiel H A van Hooff  3 , Jan Peter de Bruin  4 , Harold R Verhoeve  5 , Femke Mol  6 , Kimiko A Kleiman-Broeze  7 , Maaike A F Traas  8 , Guido J J M Muijsers  9 , Arentje P Manger  10 , Judith Gianotten  11 , Cornelia H de Koning  12 , Aafke M H Koning  13 , Neriman Bayram  14 , David P van der Ham  15 , Francisca P J M Vrouenraets  16 , Michaela Kalafusova  17 , Bob I G van de Laar  18 , Jeroen Kaijser  19 , Miriam F van Oostwaard  20 , Wouter J Meijer  21 , Frank J M Broekmans  22 , Olivier Valkenburg  23 , Lucy F van der Voet  24 , Jeroen van Disseldorp  25 , Marieke J Lambers  26 , Henrike E Peters  2 , Marit C I Lier  2 , Cornelis B Lambalk  2 , Madelon van Wely  27 , Patrick M M Bossuyt  27 , Jaap Stoker  28 , Fulco van der Veen  6 , Ben W J Mol  29 , Velja Mijatovic  2
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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 et al. BMC Womens Health. .

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 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.

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

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Conflict of interest statement

Ethics approval and consent to participate

This study is approved by the National Central Committee on Research involving Human Subjects (CCMO – NL50484.029.14), by the ethics committee of the VU Medical Centre Amsterdam (Ref. No. 2014/454) which suffices for all participating centers under Dutch law and by the boards of all participating hospitals. The trial is registered in the Dutch Trial Register (NTR 4746, http://www.trialregister.nl).

Eligible women receive oral and written information during their regular outpatient visit by the attending gynecologist or fertility doctor. Women will be contacted by telephone for further information by the investigator. Women who agree to participate will be asked to sign written informed consent, of which they will receive a copy at their next visit, when the informed consent form will also be signed by the investigator, supervising gynecologist, the attending registrar or fertility doctor.

Competing interests

VM received a grant from ZonMW (see funding) to execute this trial. IQ Medical Ventures provides the ExEm FOAM® kits. The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart FOAM study. 1Management based on the prognostic model of Hunault for natural conception: > 30%: 6 months expectant, followed by 6 cycles intrauterine insemination (IUI); < 30%: 6 cycles IUI, followed by in-vitro fertilization (IVF). 2Questionnaires: Short-Form-36 (SF-36), Health and Labour Questionnaire (HLQ)
See this image and copyright information in PMC

References

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