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


- candidate number27578
- NTR NumberNTR6590
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2017
- Secondary IDs843002807 ZonMw
- Public TitleHome-based monitoring of ovulation to time frozen embryo transfer in IVF
- Scientific TitleAssessing 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.
- ACRONYMANTARCTICA 2
- hypothesisTrue NC-FET is non-inferior to modified NC-FET in ongoing pregnancy rate after one FET cycle.
- Healt Condition(s) or Problem(s) studiedIVF, ICSI
- Inclusion criteriaWomen that have undergone IVF/ICSI who are scheduled for frozen embryo transfers.
- Exclusion criteriaWomen without ovulation (POI, PCOS)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-dec-2017
- planned closingdate29-dec-2022
- Target number of participants1464
- InterventionsINTERVENTION: 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.
- Primary outcomeOngoing pregnancy per woman
- Secondary outcomeCancellation rates, patient satisfaction (anxiety, contentedness, feeling of empowerment, discretion), partner participation, miscarriage rates, Live birth rates, costs
- TimepointsA 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.
- Trial web sitehttp://www.studies-obsgyn.nl/antarctica2
- statusplanned
- CONTACT FOR PUBLIC QUERIESdr. F. Mol
- CONTACT for SCIENTIFIC QUERIESdr. F. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
the Netherlands Organisation for Health Research and Development, ZonMw, ZonMw Doelmatigheid
- Publications
- Brief summarySummary
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.
- Main changes (audit trail)
- RECORD23-jul-2017 - 12-okt-2017


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