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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001635-36 | EudraCT Number |
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Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daifert | Experimental | • Interventional Group: The embryo to be transferred is selected on the basis of both morphological assessment performed on Day 2 or 3 and FF G-CSF concentration. FF G-CSF concentration will be measured with the Diafert® immunoassay. |
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| Control Group | Other | Control Group: The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daifert | Device |
| ||
| Control Group |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successful implantations | The percentage of successful implantation 6 weeks after oocyte retrieval (±3 days), i.e. at approximately 8 weeks gestational age (±3 days) or 8 weeks of amenorrhea (± 3 days), in each group (Control and Interventional groups), overall and within each morphological embryo category, when elective Single Embryo Transfer (SET) is performed on Day 2 or 3. Successful implantation is defined as the presence in the uterus of at least one gestational sac with fetal heart activity identified on ultrasound. | At Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of live births | Percentage of live birth in the Control group and in the Interventional group when elective SET of a fresh embryo is performed on Day 2 or 3 after oocyte retrieval. | Approximately Week 40 (pregnancy outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tennador Sanderson | Forest Laboratories, an affiliate of Allergan plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leuven University Fertility Center | Leuven | B-3000 | Belgium |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| D008722 | Methods |