Infertility
Conditions
Keywords
infertility, embryo development
Brief summary
The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.
Detailed description
This study is a multi-center, randomized, performance study.
Interventions
DEVICESMART System
microfluidic embryo culture system
DEVICECulture dish
Standard IVF culture dish
Sponsors
Incept BioSystems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
- All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study: 1. Female 21 to 35 years of age inclusive 2. First or second IVF cycle 3. Not pregnant 4. No physical abnormalities that would adversely affect oocyte retrieval 5. Male factor is acceptable 6. ICSI is acceptable 7. 10 zygotes or more
Exclusion criteria
- Potential subjects are excluded from the study if any of the following conditions exist: 1. The sperm were retrieved using TESE or MESA 2. The embryos were created with either donor oocytes or donor sperm. 3. Medical condition precluding a safe pregnancy 4. Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of development of human embryos | Day 3 (t=72 hrs) |
Countries
United States
Outcome results
None listed