Infertility
Conditions
Keywords
Infertility, Embryo develpoment, IVF, ICSI, EmbryoScope
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEmbryoScope
Standard of care arm
DEVICEEmbryoScope+
Experimental arm
Sponsors
Vitrolife
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 40 years of age or younger (maternal) * 65 years of age or younger (paternal) * Fresh or frozen (including donor) sperm can be used * Fresh oocytes only (including donor) * Frozen embryos from this study can be included in the outcome portion of this study. * Single or double Blastocyst transfer only
Exclusion criteria
* 3 or more previous failed cycles * Sperm obtained by testicular biopsy * Co-culture patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Day 3 Embryos | Day 3 post retrieval | 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 5 Embryos | Day 5 post retrieval | 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+ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation Rate | 5-6 weeks post retrieval | Presence of a gestational sac |
| Pregnancy Rate | 2 weeks post retrieval | Positive Bhcg |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This includes all participants - oocytes were randomized to standard of care embryo incubator and experimental Embryoscope + | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 33.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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+
Time frame: Day 3 post retrieval
Population: Number of day 3 embryos compared in both groups
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Embryoscope + | Number of Day 3 Embryos | 42 embryos |
| Embryoscope | Number of Day 3 Embryos | 42 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+
Time frame: Day 5 post retrieval
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Embryoscope + | Number of Day 5 Embryos | 43 embryos |
| Embryoscope | Number of Day 5 Embryos | 51 embryos |
Secondary
Implantation Rate
Presence of a gestational sac
Time frame: 5-6 weeks post retrieval
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embryoscope + | Implantation Rate | 3 Participants |
| Embryoscope | Implantation Rate | 9 Participants |
Secondary
Pregnancy Rate
Positive Bhcg
Time frame: 2 weeks post retrieval
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embryoscope + | Pregnancy Rate | 4 Participants |
| Embryoscope | Pregnancy Rate | 9 Participants |