First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial.

BACKGROUND: In recent years it has become clear that fetal anomalies can already be detected at the end of the first trimester of pregnancy by two-dimensional (2D) ultrasound. This is why increasingly in developed countries the first trimester anomaly scan is being offered as part of standard care. We have developed a Virtual Reality (VR) approach to improve the diagnostic abilities of 2D ultrasound. Three-dimensional (3D) ultrasound datasets are used in VR assessment, enabling real depth perception and unique interaction. The aim of this study is to investigate whether first trimester 3D VR ultrasound is of additional value in terms of diagnostic accuracy for the detection of fetal anomalies. Health-related quality of life, cost-effectiveness and also the perspective of both patient and ultrasonographer on the 3D VR modality will be studied. METHODS: Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion. This is a randomized controlled trial with two intervention arms. The control group receives 'care as usual': a second trimester 2D advanced ultrasound examination. The intervention group will undergo an additional first trimester 2D and 3D VR ultrasound examination. Following each examination participants will fill in validated questionnaires evaluating their quality of life and healthcare related expenses. Participants' and ultrasonographers' perspectives on the 3D VR ultrasound will be surveyed. The primary outcome will be the detection of fetal anomalies. The additional first trimester 3D VR ultrasound examination will be compared to 'care as usual'. Neonatal or histopathological examinations are considered the gold standard for the detection of congenital anomalies. To reach statistical significance and 80% power with a detection rate of 65% for second trimester ultrasound examination and 70% for the combined detection of first trimester 3D VR and second trimester ultrasound examination, a sample size of 2800 participants is needed. DISCUSSION: First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations. Results of this study will provide policymakers and healthcare professionals with the highest level of evidence for cost-effectiveness of first trimester ultrasound using a 3D VR approach. TRIAL REGISTRATION: Dutch Trial Registration number NTR6309 , date of registration 26 January 2017.

Long-term follow up of couples initially randomized between immobilization and immediate mobilization subsequent to IUI.

A previous randomized clinical trial compared immobilization for 15 min with immediate mobilization subsequent to intrauterine insemination (IUI) and showed higher ongoing pregnancy rates in couples immobilizing subsequent to IUI. The current study compared the long-term effectiveness of immobilization subsequent to IUI. All couples (n = 391) included in the trial were followed for 3 years after randomization and pregnancies and treatments were recorded. After the initial trial period, couples in both groups were offered treatment according to local protocol. The primary outcome was an ongoing pregnancy during the 3 years after the initial trial. In this time period, there were 143 ongoing pregnancies in the immobilization group (n = 199 couples) and 112 ongoing pregnancies in the immediate mobilization group (n = 192). The ongoing pregnancy rates were 72% and 58%, respectively (relative risk 1.2, 95% CI 1.1-1.4). The persistent significant difference in ongoing pregnancy rates underpins the importance of immobilization after IUI. There is no valid reason to withhold women from immobilizing for 15 min after IUI.

Costs and benefits of individuals conceived after IVF: a net tax evaluation in The Netherlands.

This study evaluated the lifetime future net tax revenues from individuals conceived after IVF relative to those naturally conceived. A model based on the method of generational accounting was developed to evaluate investments in IVF. Calculations were based on average investments paid and received from the government by an individual. All costs were discounted to their net present values and adjusted for survival. The lifetime net present value of IVF-conceived individuals was -€81,374 (the minus sign reflecting negative net present value). The lifetime net present value of IVF-conceived men and women were -€47,091 and -€123,177, respectively. The lifetime net present value of naturally conceived individuals was -€70,392; respective amounts for men and women were -€36,109 and -€112,195. The model was most sensitive to changes in the growth of healthcare costs, economic growth and the discount rate. Therefore, it is concluded that, similarly to naturally conceived individuals in the Netherlands, IVF-conceived individuals have negative discounted net tax revenue at the end of life. The analytic framework described here undervalues the incremental value of an additional birth because it only considers the fiscal consequences of life and does not take into consideration broader macroeconomic benefits. This study evaluated the lifetime future net tax revenues from individuals conceived after IVF relative those naturally conceived. A model based on the method of generational accounting to evaluate investments in IVF was used. Calculations were based on average investments paid and received from the government by an individual. The lifetime net present value of IVF-conceived individuals was -€81,374 (the minus sign reflecting negative net present value). The lifetime net present value of IVF-conceived men and women were -€47,091 and -€123,177, respectively. The lifetime net present value of naturally conceived individuals was -€70,392; respective amounts for men and women were -€36,109 and -€112,195. The model was most sensitive for changes in the growth in healthcare costs, economic growth and the discount rate. Just as naturally conceived individuals in the Netherlands, IVF-conceived individuals have negative discounted net tax revenue at the end of life. The analytic framework described here undervalues the incremental value of an additional birth because it only considers the fiscal consequences of life and does not take into consideration broader macroeconomic benefits.

Cost-effectiveness of tubal patency tests.

OBJECTIVE: Guidelines are not in agreement on the most effective diagnostic scenario for tubal patency testing; therefore, we evaluated the cost-effectiveness of invasive tubal testing in subfertile couples compared with no testing and treatment. DESIGN: Cost-effectiveness analysis. SETTING: Decision analytic framework. POPULATION: Computer-simulated cohort of subfertile women. METHODS: We evaluated six scenarios: (1) no tests and no treatment; (2) immediate treatment without tubal testing; (3) delayed treatment without tubal testing; (4) hysterosalpingogram (HSG), followed by immediate or delayed treatment, according to diagnosis (tailored treatment); (5) HSG and a diagnostic laparoscopy (DL) in case HSG does not prove tubal patency, followed by tailored treatment; and (6) DL followed by tailored treatment. MAIN OUTCOME MEASURES: Expected cumulative live births after 3 years. Secondary outcomes were cost per couple and the incremental cost-effectiveness ratio. RESULTS: For a 30-year-old woman with otherwise unexplained subfertility for 12 months, 3-year cumulative live birth rates were 51.8, 78.1, 78.4, 78.4, 78.6 and 78.4%, and costs per couple were €0, €6968, €5063, €5410, €5405 and €6163 for scenarios 1, 2, 3, 4, 5 and 6, respectively. The incremental cost-effectiveness ratios compared with scenario 1 (reference strategy), were €26,541, €19,046, €20,372, €20,150 and €23,184 for scenarios 2, 3, 4, 5 and 6, respectively. Sensitivity analysis showed the model to be robust over a wide range of values for the variables. CONCLUSIONS: The most cost-effective scenario is to perform no diagnostic tubal tests and to delay in vitro fertilisation (IVF) treatment for at least 12 months for women younger than 38 years old, and to perform no tubal tests and start immediate IVF treatment from the age of 39 years. If an invasive diagnostic test is planned, HSG followed by tailored treatment, or a DL if HSG shows no tubal patency, is more cost-effective than DL.

Expanding reproductive lifespan: a cost-effectiveness study on oocyte freezing.

BACKGROUND: The average age of women bearing their first child has increased strongly. This is an important reproductive health problem as fertility declines with increasing female age. Unfortunately, IVF using fresh oocytes cannot compensate for this age-related fertility decline. Oocyte freezing could be a solution. METHODS: We used the Markov model to estimate the cost-effectiveness of three strategies for 35-year-old women who want to postpone pregnancy till the age of 40: Strategy 1: women undergo three cycles of ovarian hyperstimulation at age 35 for oocyte freezing, then at age 40, use these frozen oocytes for IVF; Strategy 2: women at age 40 attempt to conceive without treatment; and the reference strategy: women at age 40 attempt to conceive and, if not pregnant after 1 year, undergo IVF. Sensitivity analyses were carried out to investigate assumptions of the model and to identify which model inputs had most impact on the results. RESULTS: Oocyte freezing (Strategy 1) resulted in a live birth rate of 84.5% at an average cost of €10,419. Natural conception (Strategy 2) resulted in a live birth rate of 52.3% at an average cost of €310 per birth. IVF (the reference strategy) resulted in a cumulative live birth rate of 64.6% at an average cost of €7798. The cost per additional live birth for the oocyte freezing strategy was €13,156 compared to the IVF strategy. If at least 61% of the women return to collect their oocytes, and if there is a willingness to pay €19,560 extra per additional live birth, the oocyte freezing strategy is the most cost-effective strategy. CONCLUSION: Oocyte freezing is more cost effective compared to IVF, if at least 61% of the women return to collect their oocytes and if one is willing to pay €19,560 extra per additional live birth. Our Markov model shows that, considering all the used assumptions, oocyte freezing provides more value for money than IVF.