Abstract
BackgroundTubal 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/designWe 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.DiscussionThis trial will compare the effectiveness and costs of HyFoSy versus HSG in assessing tubal patency in subfertile women.Trial registrationDutch Trial Register (NTR 4746, http://www.trialregister.nl). Date of registration: 19 August 2014.
Highlights
Tubal pathology is a causative factor in 20% of subfertile couples
There is a risk for visceral damage, intra-abdominal bleeding and risks related to general anesthesia
In case the chance is less than 30%, participants will be treated with intrauterine insemination (IUI) eventually followed by in vitro fertilization (IVF)
Summary
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. The diagnostic work-up for subfertility includes tests to assess tubal status, among which hysterosalpingography (HSG) and diagnostic laparoscopy with chromopertubation (DLS) are the most established tests [2]. In 2011, hysterosalpingo-foam sonography (HyFoSy) was introduced as a new technique for tubal patency testing and an alternative for HyCoSy [5]. This imaging technique is comparable to HyCoSy, but it uses foam instead of gel
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