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ID
Source
Health condition
Assisted reproductive technologies help overcoming many causes of infertility, and are widely used all over the world. Unfortunately efficiencies of the current technologies remain relatively low with pregnancy rates of only 20-30% per embryo transfer. This may be due to the format of the culture (static drops covered with oil), culture parameters (e.g. medium composition), extensive manipulation of the embryos and the inability to identify the most viable embryo. Therefore new approaches are needed to improve in vitro culture conditions and increase take home baby rates.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the blastocyst formation rate on day 5, 28 hours after thawing, in both, the control and experimental group.
Secondary outcome
The 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.
Background summary
Validation 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.
Study objective
The blastocyst formation rate of frozen-thawed donated human pre-implantation embryos cultured in a microfluidic platform is higher than in a standard culture dish.
Study design
The 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.
Intervention
Frozen-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.
D.C. Kieslinger
Amsterdam 1081 JC
The Netherlands
+31 (0)20 4442935
d.kieslinger@vumc.nl
D.C. Kieslinger
Amsterdam 1081 JC
The Netherlands
+31 (0)20 4442935
d.kieslinger@vumc.nl
Inclusion criteria
Frozen-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 criteria
Embryos with insufficient morphological quality after thawing will be excluded from the study according to the criteria described above.
Design
Recruitment
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL3697 |
| NTR-old | NTR3867 |
| CCMO | NL38300.000.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |