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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: EmbryoGlue | Experimental | Embryo transfer with EmbryoGlue® |
|
| Control group | Active Comparator | Conventional embryo transfer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmbryoGlue®, Vitrolife | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | live birth per randomized subject. | 9 months after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| positive hCG | cumulative positive hCG rate confirmed by blood sample | 11 days (± 2 days) after embryo transfer. |
| ongoing pregnancy rate | cumulative ongoing pregnancy rate per randomized subject, confirmed by ultrasound |
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Inclusion Criteria:
Furthermore, other specific 'RIF' investigations were performed and treated if necessary:
Exclusion Criteria:
• Simultaneous participation in another clinical study
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| Name | Affiliation | Role |
|---|---|---|
| Dominic Stoop, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Ghent | Recruiting | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D020964 | Embryo Loss |
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Conventional Transfer | Drug | The control arm is the conventional embryo transfer without Embryo glue medium |
|
| between 6 and 8 weeks of gestation |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |