Home-based monitoring of ovulation to time frozen embryo transfer in IVF

Summary

OBJECTIVE(S)/RESEARCH QUESTION(S): Assessing cost-effectiveness of home based monitoring with urinary LH tests (true natural cycle frozen embryo transfer, true NC-FET) versus hospital controlled monitoring with repeated ultrasound monitoring and hCG trigger (modified NC-FET) to time frozen embryo transfer in IVF.

HYPOTHESIS: True NC-FET is non-inferior to modified NC-FET in ongoing pregnancy rate after one FET cycle.

STUDY DESIGN: Multicentre, non-inferiority RCT with a cost-effectiveness analysis.

STUDY POPULATION(S)/DATASETS: Women that have undergone IVF/ICSI who are scheduled for frozen embryo transfers.

INTERVENTION: True natural cycle FET with home-based monitoring of ovulation with urinary LH tests

USUAL CARE /COMPARISON: Modified NC-FET with repeated ultrasound monitoring of the dominant follicle followed by hCG trigger.

OUTCOME MEASURES: Ongoing pregnancy per woman after a single FET cycle.

SAMPLE SIZE CALCULATION/DATA ANALYSIS: We expect a 12% ongoing pregnancy rate per started cycle per woman after modified NC FET. To evaluate whether true NC-FET does not result in a decrease of ongoing pregnancy rate of 4%(non-inferiority design), we need 1390 patients with a power of 80% and an alpha error of 0.05. Anticipating 5% lost to follow up we need to randomise 1464 women.

COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS: If home-based monitoring is cost-effective, an annual cost reduction of 3 to 4 million Euro can be achieved.

TIME SCHEDULE: A total of 60 months, consisting of 12 months preparation, 36 months for recruitment, 10 months for followup and 2 months data analysis and reporting.

True NC-FET is non-inferior to modified NC-FET in ongoing pregnancy rate after one FET cycle.

A total of 60 months, consisting of 12 months preparation, 36 months for recruitment, 10 months for follow up and 2 months data analysis and reporting.

INTERVENTION: True natural cycle FET with home-based monitoring of ovulation with urinary LH tests.

USUAL CARE /COMPARISON: Modified NC-FET with repeated ultrasound monitoring of the dominant follicle followed by hCG trigger.