Is Hysterosalpingo-Foam Sonografie (HyFoSy) een kosteneffectief alternatief voor hysterosalpingografie (HSG) als tubadoorgankelijkheidstest in subfertiele vrouwen?

OBJECTIVE: To investigate if tubal patency testing during the fertility work-up by hysterosalpingo-foam sonography (HyFoSy) is more cost-effective compared to hysterosalpingography (HSG).

HYPOTHESIS: We hypothesize that HyFoSy has comparable diagnostic accuracy as HSG for a 50% lower cost.

STUDY DESIGN: We plan a multicenter prospective study of women undergoing tubal patency testing by HyFoSy and HSG in a random order during fertility work-up (RCT1). Women in this study with discordant test results will be randomized for management strategy based on HyFOSy or HSG resulting in a diagnostic laparoscopy with chromopertubation (DLS) or an management based on the prognostic model of Hunault (RCT2). Data will be used in a model based cost-effectiveness analysis.

STUDY POPULATION: Subfertile women scheduled for tubal patency testing.

INTERVENTIONS: Fertility work-up based on HyFoSy.

STANDARD INTERVENTION TO BE COMPARED TO: Fertility work-up based on HSG.

DESIGN: Women will undergo HyFoSy as well as HSG in a random order. Participants with discordant tests results (and therefore apply for different clinical treatments depending on which test was used), will be randomized for for a management strategy based on HyFoSy or HSG resulting in a DLS or a management based on the prognostic model of Hunault. From these data a strategy of outpatient tubal patency testing based on the new technique HyFoSy will be compared with a strategy of tubal patency testing based on HSG.

OUTCOME MEASURES: Ongoing pregnancy rates within 12 month after inclusion. Costs and effectiveness will be analyzed.

SAMPLE SIZE: We propose a non-inferiority effectiveness trial. Under the assumption of a 7% discordance rate between the results of HyFoSy and HSG, we need to randomize 82 women (power 80%) to demonstrate the non-inferiority of HyFoSy (difference < 2%). Basedon the anticipated 7% discordance rate we need to include a total of 1163 women in the study.

COST-EFFECTIVENESS ANALYSIS/BUDGET IMPACT ANALYSIS: The average costs and effectiveness of a strategy of tubal patency testing during fertility work up by HyFoSy or HSG as first line test will be compared. Fertility treatment and pregnancy outcomes will be evaluated after a follow-up of 12 months. Assuming that 20.000 HSGs are made annually in the Netherlands and a difference in cost of €100 in favor of HyFoSy, the budget impact will estimates a saving of over €2 million in case of non-inferiority.

TIME SCHEDULE: month 1-3: preparation; month 4-33 inclusion and follow- up; month 34-36 data analyses and reporting.

We hypothesize that a strategy of tubal patency testing during the fertility work-up by HyFoSy results in equal diagnostic outcomes and subsequent management decisions, which lead to similar ongoing pregnancy rates as a strategy of tubal testing by HSG, but tor lower cost.

Primary outcome: 12 months after inclusion
Quality of life questionaires: one day before randomisation, and after 3, 6 and 12 months after inclusion.

RCT1: Hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingography (HSG) in a random order. In case of discordance test results between HyFoSy and HSG women will be included in RCT 2: management strategy based on HSG or HyFoSy resulting in a diagnostic laparoscopy with chromopertubation or an management according to the prognostic model of Hunault. <1x10^6/ml