Embryo Loss, IVF, Miscarriage, Recurrent
Conditions
Brief summary
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.
Interventions
DRUGEmbryoGlue®, Vitrolife
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.
DRUGConventional Transfer
The control arm is the conventional embryo transfer without Embryo glue medium
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* The trial only includes women with a clinical indication for ART with a history of RIF defined as the absence of implantation after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos was no less than four for cleavage-stage embryos and no less than two for blastocysts, with all embryos being of good quality and of appropriate developmental stage. Furthermore, other specific 'RIF' investigations were performed and treated if necessary: * Normal hysteroscopy * Normal karyotype of both parents * Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APC resistance, Factor V + Factor II augmentation, Protein S and C deficiency an homocysteine augmentation) * Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclear antibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)
Exclusion criteria
* • Simultaneous participation in another clinical study * Untreated and uncontrolled thyroid dysfunction * Tumors of the ovary, breast, uterus, pituitary or hypothalamus * Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause * Ovarian cysts or enlarged ovaries * Malformations of the reproductive organs * Moderate or severe hepatic impairment * Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy * Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation * Couples needing TESE/MESA material
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth | 9 months after embryo transfer | live birth per randomized subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| positive hCG | 11 days (± 2 days) after embryo transfer. | cumulative positive hCG rate confirmed by blood sample |
| ongoing pregnancy rate | between 6 and 8 weeks of gestation | cumulative ongoing pregnancy rate per randomized subject, confirmed by ultrasound |
Countries
Belgium
Outcome results
None listed