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Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnancy test | Diagnostic Test | Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Early Detection of Pregnancy | Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer) | One month |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto Bosch, MDPhD | IVIRMA VALENCIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Valencia | Valencia | 46003 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Early Detection of Pregnancy | Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer) | From the 155 patients, 13 were excluded from analysis for several issues. | Posted | Count of Participants | Participants | One month |
|
|
10 MONTH
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LAURA CARACENA (STUDY COORDINATOR) | IVIValencia | 034 963050900 | laura.caracena@ivirma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2017 | Feb 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011258 | Pregnancy Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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All the patients will undergo 3 blood samples for analyses to determine pregnancy.
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| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 156 |
| 0 |
| 156 |
| 0 |
| 156 |
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| D008919 | Investigative Techniques |