This is a pilot study with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (EmbryoGlue®, Vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
178
The intervention under study is the application of EmbryoGlue®, a class III medical device (CE Marked). EmbryoGlue® is a bicarbonate buffered medium containing recombinant human albumin, hyaluronan and gentamicin as an antibacterial agent.
The control arm is the conventional embryo transfer without Embryo glue medium
UZ Ghent
Ghent, Belgium
RECRUITINGLive birth
live birth per randomized subject.
Time frame: 9 months after embryo transfer
positive hCG
cumulative positive hCG rate confirmed by blood sample
Time frame: 11 days (± 2 days) after embryo transfer.
ongoing pregnancy rate
cumulative ongoing pregnancy rate per randomized subject, confirmed by ultrasound
Time frame: between 6 and 8 weeks of gestation
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