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Microfluidic embryo culture.


- candidate number14421
- NTR NumberNTR3867
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-feb-2013
- Secondary IDsNL38300.000.11 CCMO
- Public TitleMicrofluidic embryo culture.
- Scientific TitleMicrofluidic culture of human embryos for ART.
- ACRONYM
- hypothesisThe blastocyst formation rate of frozen-thawed donated human pre-implantation embryos cultured in a microfluidic platform is higher than in a standard culture dish.
- Healt Condition(s) or Problem(s) studiedEmbryo
- Inclusion criteriaFrozen-thawed donated human embryos of sufficient morphological quality will be included in the study. The following criteria have to be met after thawing:
1. Minimum number of blastomeres: 8 cells;
2. Maximum degree of fragmentation: 20%;
3. Maximum degree of atresia: 25%.
- Exclusion criteriaEmbryos with insufficient morphological quality after thawing will be excluded from the study according to the criteria described above.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-aug-2012
- planned closingdate1-dec-2013
- Target number of participants400
- InterventionsFrozen-thawed human embryos are either cultured in standard culture dishes or in microfluidic systems which enable the collection of essential information on the development of the embryos.
- Primary outcomeThe main study endpoint is the blastocyst formation rate on day 5, 28 hours after thawing, in both, the control and experimental group.
- Secondary outcomeThe secondary study parameter is the morphology of each embryo at different time points. The percentage of embryos that reach each developmental stage will be recorded and analysed as secondary study endpoints. Furthermore we will assess how many embryos are suitable for embryo transfer one day after thawing according to standard laboratory criteria.
- TimepointsThe project will approximately take 18 months in total. Only the first and third steps of the project will involve the culture of frozen-thawed donated human embryos.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D.C. Kieslinger
- CONTACT for SCIENTIFIC QUERIES D.C. Kieslinger
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Merck Serono S.A. Geneva
- PublicationsN/A
- Brief summaryValidation of a microfluidic platform for the pre-implantation culture of individual human embryos and their on-line assessment using an integrated multi-parametric approach: morphological criteria, oxygen consumption and metabolic activity.
- Main changes (audit trail)
- RECORD21-feb-2013 - 10-mrt-2013


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