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
(2018) BMC Women's Health, volume 18, issue 1, pp. 1 - 7
(Article)
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
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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.
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Keywords: Budget impact, Cost-effectiveness, Fertility work-up, Hysterosalpingo foam sonography (HyFoSy), Hysterosalpingography (HSG), Ongoing pregnancy, Randomized controlled trial, Subfertility, Tubal patency testing, Pain, Procedural/etiology, Ovulation Induction, Humans, Infertility, Female/diagnostic imaging, Young Adult, Multicenter Studies as Topic, Adult, Female, Pregnancy Rate, Fallopian Tube Diseases/complications, Live Birth, Reproductive Techniques, Assisted, Randomized Controlled Trials as Topic, Pregnancy, Hysterosalpingography/adverse effects, Ultrasonography/adverse effects, Fallopian Tubes/diagnostic imaging, Adolescent, Laparoscopy/adverse effects, Abortion, Spontaneous/etiology, Research Design, Cost effectiveness, Reproductive Medicine, Obstetrics and Gynaecology, Research Support, Non-U.S. Gov't, Journal Article
ISSN: 1472-6874
Publisher: BioMed Central
Note: Funding Information: 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. Funding Information: 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. Publisher Copyright: © 2018 The Author(s).
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