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Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-Test diagnosis and Day 3 transfer | Experimental | Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos + the extra cumulus cell based diagnosis and transfer of the best embryo based on morphology and CC diagnosis on day 3 of embryo growth (cleavage stage embryo) |
|
| Day 3 transfer control group | No Intervention | Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 3 of embryo growth (cleavage stage embryo) | |
| Day 5 transfer control group | No Intervention | Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 5 of embryo growth (blastocyst stage embryo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-Test | Diagnostic Test | Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy as observed by ultrasound | This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database | 2 months after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Positive beta-hCG pregnancy as observed by serum analysis | This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database | 12-17 days after embryo transfer |
| Live birth by questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inge Van Vaerenbergh, PhD | Contact | +32 2 477 46 45 | inge.vanvaerenbergh@uzbrussel.be | |
| Tom Adriaenssens, MSc | Contact | +32 2 477 46 45 | tom.adriaenssens@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Johan Smitz, Prof. Dr. | Universitair Ziekenhuis Brussel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database. This measurement does not include a scale, there is either a child born or not. The date of delivery and the gender of the child are asked together with eventual complications. |
| at least 9 months after embryo transfer |
| Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3) | This is the compilation of the data gathered in outcome 1 and 3 for eventual consecutive cycles. This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database | 2 years after embryo transfer |