Abstract
Abstract Study question Is transvaginal hydrolaparoscopy (THL) cost-effective compared to hysterosalpingography (HSG) in the work-up for subfertility in a population at low-risk for tubal pathology? Summary answer THL is cost-effective compared to HSG in a preselected group of women at low-risk of tubal pathology. What is known already Tubal pathology is a common cause of subfertility and tubal patency testing plays an important part in the work-up of the subfertile couple and the subsequent counseling for fertility treatment. THL is an out-patient procedure. After access through the pouch of Douglas, the tubes and pelvic cavity are directly observed using hydroflotation, whereas HSG is a radiographic evaluation of the uterine cavity and patency of the tubes with injection of contrast medium in the uterine cavity. Both methods are safe and feasible for subfertile women at low-risk of tubal pathology. Study design, size, duration We performed an economic analysis as part of a randomized controlled trial comparing THL and HSG in the work-up for subfertility. Women were eligible if they had an indication for evaluation of tubal patency. Primary outcome was a conception leading to live birth in 24 months. We randomly assigned 300 subfertile women to THL or HSG between May 2013 and October 2016. Participants/materials, setting, methods This study was performed in four Dutch teaching hospitals. The economic evaluation was performed from a health care perspective. Costs were either derived from literature or calculated. The mean costs and outcomes for each treatment group were compared. Costs were combined with effectiveness by calculating ICER, and bootstrap resampling was performed. We generated a cost-effectiveness plane and cost-effectiveness acceptability curves. Main results and the role of chance After 24 months of follow-up there was a 3% difference in live birth rate in favour of the THL group (58.5% in the THL group versus 55.4% in the HSG group (83/142 versus 82/148 difference 3.0% (95% CI: -8.3 – 14.4)). Multiple pregnancy and miscarriage rate were low and did not differ between groups. Ectopic pregnancy occurred in two women in the HSG group and not in the THL group. The mean cost was lower in the THL group, compared to the HSG group (THL group 4,927 EUR versus 5,197 EUR in the HSG group, difference -270 EUR). Although the costs of the diagnostic procedure itself were higher in the THL group (425 EUR versus 289 EUR, difference 136 EUR), the costs for fertility treatments are higher in the HSG group. The base case outcome is that THL costs less and is more effective than HSG, making THL the dominant strategy. The spread of the bootstrap indicates that there is uncertainty regarding the effectiveness of THL over HSG but less uncertainty regarding the cost difference between THL and HSG. Limitations, reasons for caution This trial was conducted in the Netherlands, using price calculations of the Dutch healthcare system in Euro’s. Since prices of fertility treatments and especially ART or fertility enhancing surgery can vary widely worldwide, it is possible that the outcomes of our study are not generalizable to other countries. Wider implications of the findings The findings of our trial suggest that in a preselected group of women with low risk for tubal pathology, a diagnostic strategy starting with THL is cost-effective compared to a diagnostic strategy starting with HSG in the workup for subfertility. Trial registration number NTR3462
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