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van CCT (UK)

van CCT (UK)

Time-lapse monitoring in IVF and ICSI patients

- candidate number22843
- NTR NumberNTR5423
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2015
- Secondary IDs843001602 
- Public TitleTime-lapse monitoring in IVF and ICSI patients
- Scientific TitleEmbryo SELECtion using TIme-lapse MOnitoring in IVF and ICSI patients
- hypothesisEmbryo selection using the Geri+ time-lapse system in combination with the Eeva Test (Early Embryo Viability Assessment) will increase the (cumulative) ongoing pregnancy rate of IVF and ICSI patients and thereby balance additional costs of TLM (time-lapse monitoring) equipment.
- Healt Condition(s) or Problem(s) studiedSubfertility
- Inclusion criteriaWomen scheduled for a single embryo transfer (SET) during their first IVF or ICSI cycle at any of the participating IVF centers will be considered for inclusion.
- Exclusion criteriaPatients with a double embryo transfer, a planned ‘freeze all’ cycle without a fresh embryo transfer, or participation in an interfering scientific study will not be included in the study. Patients who are treated with donor sperm or donor oocytes will be excluded. Also patients scheduled for PGD or thawing of oocytes after vitrification will be excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2017
- planned closingdate1-mrt-2020
- Target number of participants1740
- InterventionsA) Embryo selection based on Eeva Results and continuous culture in Geri+ incubator (Geri+Eeva complete) and B) Routine embryo selection based on morphology and continuous culture in Geri+ incubator (Geri culture only) will be compared to C) Routine embryo selection based on morphology and interrupted culture in Geri+ incubator (Control). Embryos in all three groups will be cultured in the Geri+ time-lapse incubator.
- Primary outcomeThe main study parameters are the ongoing pregnancy rate of the first fresh SET and the cumulative ongoing pregnancy rate including the first fresh SET and all subsequent cryo transfers from the same ovum pick up cycle within one year.
- Secondary outcomeThe following secondary and exploratory endpoints will be analyzed: biochemical pregnancy rate and live birth rate after fresh SET, cumulative live birth rate, miscarriage rate, time to pregnancy, embryo morphology and number of usable embryos (ie embryos used for transfer or cryopreservation), morphokinetic parameters, pregnancy rates in three female age groups, cost-efficiency, outcome of manual time-lapse annotations.
- TimepointsN/A
- Trial web siteVU University Medical Center Amsterdam
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Serono Benelux B.V.
- Publications
- Brief summaryThe SelecTIMO study is a multicenter, three-armed, randomized, controlled, double blind trial. It will establish whether the use of time-lapse monitoring for embryo culture and embryo selection can outperform routine morphological embryo culture and selection. Furthermore, this trial will reveal whether an improvement of the clinical outcome is mediated through the stable culture environment and/or optimized selection method using Eeva time-lapse Results.
- Main changes (audit trail)
- RECORD8-sep-2015 - 5-mrt-2017

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