Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of Day 3 Embryos
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Number of Day 3 Embryos
Time Frame: 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
Time Frame: 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 Outcomes
- Pregnancy Rate(2 weeks post retrieval)
- Implantation Rate(5-6 weeks post retrieval)