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The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.
This study is a Phase IV, open label, prospective, randomized, exploratory, multicenter study. Subjects were randomized in 2:1 ratio to two treatment groups: in the experimental group, embryos were assessed for embryo transfer (ET) with Eeva and morphological grading, while in the control group embryos were assessed with morphological grading only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Embryo Viability Assessment + Morphological Grading | Experimental | Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer. |
|
| Morphological Grading | No Intervention | Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eeva | Device | Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implantation Rate | Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100. | Gestational Weeks 5 to 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | Clinical pregnancy was confirmed by the presence of a gestational sac with heartbeat as assessed by ultrasonography. Clinical pregnancy rate was measured as the number of clinical pregnancies divided by number of embryo transfer (ET) cycles multiplied by 100. | Gestational Weeks 5 to 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 3 Embryo Transfer (ET) | Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the instructions for use (IFU) of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambrian Wellness Centre | Calgary | Alberta | Canada | |||
| One Fertility |
A total of 976 subjects were enrolled, out of which 970 subjects were randomized and started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Embryo Viability Assessment + Morphological Grading | Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer. |
| FG001 | Morphological Grading | Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Embryo Viability Assessment + Morphological Grading | Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer. |
| BG001 | Morphological Grading |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Implantation Rate | Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100. | The intention-to-treat population included all randomized subjects. | Posted | Number | 95% Confidence Interval | % of sacs per embryo transferred | Gestational Weeks 5 to 8 |
|
Not Applicable (NA)
This is a fertility device technology study and this study was not designed to monitor all-cause mortality, serious, and other (not Including serious) adverse events. Therefore, all-cause mortality, serious, and other (not Including serious) adverse events data could not be reported.
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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 | Early Embryo Viability Assessment + Morphological Grading | Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer. |
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Subgroup analysis revealed high incidence of Eeva noncompliance in the experimental arm and heterogeneous results across sites. Thus, no decisive conclusion can be made from this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2016 | Feb 8, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2017 | Feb 8, 2018 | SAP_001.pdf |
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| Number of Subjects With Ongoing Pregnancy Status |
Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by ultrasonography at gestational week 10-12. Number of subjects with ongoing pregnancy status has been reported, where "Yes" indicates participants with positive ongoing pregnancy status and "No" indicates participants with negative ongoing pregnancy status . |
| Gestational Weeks 10 to 12 |
| Multiple Pregnancy Rate | Multiple pregnancy rate was defined as a clinical pregnancy with greater than equals to (>=) 2 fetal sacs as assessed by ultrasonography. Multiple Pregnancies rate was measured by number of multiple pregnancies divided by number of embryo transfer cycles multiplied by 100. | Gestational Weeks 5 to 8 |
| Utilization Rate | Utilization rate was defined as the sum of number of transferred and frozen embryos divided by number of normally fertilized oocytes multiplied by 100. | Day 3 or Day 5/6 of embryo culture |
| Spontaneous Miscarriage Rate | Spontaneous miscarriage rate was measured by the number of spontaneous miscarriages as communicated during medical appointment or by telephone contact divided by number of clinical pregnancies multiplied by 100. | Gestational Weeks 10 to 12 |
| Day 3 of embryo culture |
| Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 5/6 Embryo Transfer (ET) | Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the IFU of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure. | Day 5/6 of embryo culture |
| Burlington |
| Ontario |
| Canada |
| ISIS Regional Fertility Clinic | Mississauga | Ontario | Canada |
| Mount Sinai Hospital | Toronto | Canada |
| Rigshospitalet | Copenhagen | Denmark |
| CHRU - Hopital Jeanne de Flandres | Lille | France |
| Laboratoire Alphabio & Institut de Médecine de la Reproducti | Marseille | France |
| Hopital Hotel Dieu | Nantes | France |
| Universitatsklinik Schleswig-Holstein | Lübeck | Germany |
| Kinderwunsch Centrum München | Munich | Germany |
| MVZ Kinderwunschzentrum Wiesbaden GmbH | Wiesbaden | Germany |
| Montichiari Università degli studi di Bresca | Montichiari | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| Università degli Studi Torino | Torino | Italy |
| Ospedale Versilia | Viareggio | Italy |
| Telemark hospital Porsgrunn | Skien | Norway |
| ClÃnica Vistahermosa | Alicante | Spain |
| Clinica Sagrada Familia | Barcelona | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Spain |
| Fertilitetscentrum Stockholm | Stockholm | Sweden |
| Bourn Hall | Cambridge | United Kingdom |
| Birmingham Women's Health Care NHS Trust | Edgbaston | United Kingdom |
| Homerton University Hospital | London | United Kingdom |
Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Clinical Pregnancy Rate | Clinical pregnancy was confirmed by the presence of a gestational sac with heartbeat as assessed by ultrasonography. Clinical pregnancy rate was measured as the number of clinical pregnancies divided by number of embryo transfer (ET) cycles multiplied by 100. | The intention-to-treat population included all randomized subjects. | Posted | Number | 95% Confidence Interval | Percentage of pregnancy per transfer | Gestational Weeks 5 to 8 |
|
|
|
| Secondary | Number of Subjects With Ongoing Pregnancy Status | Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by ultrasonography at gestational week 10-12. Number of subjects with ongoing pregnancy status has been reported, where "Yes" indicates participants with positive ongoing pregnancy status and "No" indicates participants with negative ongoing pregnancy status . | The intention-to-treat population included all randomized subjects. | Posted | Number | Subjects | Gestational Weeks 10 to 12 |
|
|
|
| Secondary | Multiple Pregnancy Rate | Multiple pregnancy rate was defined as a clinical pregnancy with greater than equals to (>=) 2 fetal sacs as assessed by ultrasonography. Multiple Pregnancies rate was measured by number of multiple pregnancies divided by number of embryo transfer cycles multiplied by 100. | The intention-to-treat population included all randomized subjects. | Posted | Number | 95% Confidence Interval | Percentage of pregnancy per transfer | Gestational Weeks 5 to 8 |
|
|
|
| Secondary | Utilization Rate | Utilization rate was defined as the sum of number of transferred and frozen embryos divided by number of normally fertilized oocytes multiplied by 100. | The intention-to-treat population included all randomized subjects. | Posted | Number | 95% Confidence Interval | Percentage of embryos | Day 3 or Day 5/6 of embryo culture |
|
|
|
| Secondary | Spontaneous Miscarriage Rate | Spontaneous miscarriage rate was measured by the number of spontaneous miscarriages as communicated during medical appointment or by telephone contact divided by number of clinical pregnancies multiplied by 100. | The intention-to-treat population included all randomized subjects. | Posted | Number | Percentage of miscarriages | Gestational Weeks 10 to 12 |
|
|
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| Other Pre-specified | Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 3 Embryo Transfer (ET) | Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the instructions for use (IFU) of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure. | Subgroup Analysis Set included subjects from "Early Embryo Viability Assessment + morphology grading" group for whom the embryologist has followed the recommendation of the Eeva system. Here, Number of Subjects analyzed signifies those who were evaluable for this outcome measure. | Posted | Number | Subjects | Day 3 of embryo culture |
|
|
|
| Other Pre-specified | Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 5/6 Embryo Transfer (ET) | Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the IFU of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure. | Subgroup Analysis Set included subjects from "Early Embryo Viability Assessment + morphology grading" group for whom the embryologist has followed the recommendation of the Eeva system. Here, Number of Subjects analyzed signifies those who were evaluable for this outcome measure. | Posted | Number | Subjects | Day 5/6 of embryo culture |
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| Post-Hoc | Number of Sites With Subjects Reporting Fetal Heart Beat (FHB) Positive Implantation Rate (IR) | Number of sites with subjects reporting fetal heart beat (FHB) positive implantation rate (IR) were reported. Overall combined data for "Early Embryo Viability Assessment + Morphological Grading" and "Morphological Grading" arm was planned to be reported. | Subgroup analysis set included subjects reporting positive fetal heart beat implantation rate from both "Early Embryo Viability Assessment and Morphological grading arm" and "Morphological grading arm". Here, Number of Subjects analyzed signifies those who were evaluable for this outcome measure. | Posted | Number | Sites | Gestational Weeks 5 to 8 | Sites | Sites |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Morphological Grading | Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Day 5/6 of embryo transfer |
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