Not provided
Not provided
Not provided
Not provided
Not provided
Device has been FDA approved.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vitrolife | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.
This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.
Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.
"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.
Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EmbryoScope | Active Comparator | Standard of care embryo incubator. |
|
| EmbryoScope+ | Experimental | New experimental embryo incubator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmbryoScope | Device | Standard of care arm |
| |
| EmbryoScope+ |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Day 3 Embryos | Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+ | Day 3 post retrieval |
| Number of Day 5 Embryos | Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+ | Day 5 post retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation Rate | Presence of a gestational sac | 5-6 weeks post retrieval |
| Pregnancy Rate | Positive Bhcg | 2 weeks post retrieval |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Maternal age- 40 years of age or younger Paternal age- 65 years of age or younger
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nikica Zaninovic, PhD | Center for Reproductive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Reproductive Medicine | New York | New York | 10065 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
18 subjects will undergo IVF. Participant's oocytes at retrieval will be randomly assigned to both groups for comparison: Standard EmbryoScope system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated. "Best grade" embryos will be transferred regardless of EmbryoScope use.
Patients undergoing IVF were be recruited to participate in the study. Those agreeing to participate consented to have their embryos incubated in the new Embryoscope+ as opposed to the current one being used as standard of care.
| ID | Title | Description |
|---|---|---|
| FG000 | Embryoscope + | Embryoscope + |
| FG001 | Embryoscope | Embryoscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This includes all participants - oocytes were randomized to standard of care embryo incubator and experimental Embryoscope + |
| 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 Day 3 Embryos | Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+ | Number of day 3 embryos compared in both groups | Posted | Count of Units | embryos | Day 3 post retrieval | embryos | embryos |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants Enrolled | All participants enrolled and randomized to Embryoscope and Embryoscope+ |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikica Zaninovic, PhD | Weill Cornell Medical College | 212-746-5790 | nizanin@med.cornell.edu |
Not provided
| 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 17, 2018 | May 6, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020669 | Fetoscopes |
| ID | Term |
|---|---|
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
Experimental arm |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| embryos |
|
|
| Primary | Number of Day 5 Embryos | Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+ | Posted | Count of Units | embryos | Day 5 post retrieval | embryos | embryos |
|
|
|
| Secondary | Implantation Rate | Presence of a gestational sac | Posted | Count of Participants | Participants | 5-6 weeks post retrieval |
|
|
|
| Secondary | Pregnancy Rate | Positive Bhcg | Posted | Count of Participants | Participants | 2 weeks post retrieval |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
Not provided
Not provided
Not provided