ART
Conditions
Keywords
Group embryo culture, Low oxygen tension, Closed station, Embryo handling
Brief summary
There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than individual culture at atmospheric oxygen tension (20% O2) in a conventional incubator. For these reasons, the investigators have decided to continue this research line to evaluate the efficacy of a new ART station with a closed environment in comparison of an open flow cabinet. This new system keeps a controled environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37 degrees. A prospective randomized study will be carried out in which the manipulation of the gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or in a closed station that maintain the CO2 and temperature conditions.
Interventions
OTHEREmbryo handling in a closed station
Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.
Sponsors
Vida Recoletas Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Signing a written consent to participate in the study. * Blastocyst transfer: * Patients using their own oocytes under 40 years. * Patients using donated oocytes.
Exclusion criteria
* Preimplantation genetic screening patients. * Severe male factor (spermatozoa of testicular or epididymal origin, patients with cryptozoospermia and patients with retrograde ejaculation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Embryo quality | Through study completion, an average of two years | Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate per first embryo transfer | Through study completion, an average of two years | Total number of live births over the total of recruited patients (taking into account only the first cycle) |
| Cumulative live birth rate | Through study completion, an average of two years | Total number of live births over the total of recruited patients (taking into account fresh and cryopreserved cycles) |
| Implantation rate | Through study completion, an average of two years | Total of implanted embryos / total of transferred embryos |
| Live birth rate of the first cycle per transferred embryo | Through study completion, an average of two years | Total number of live births over the total of transferred embryo |
Countries
Spain
Outcome results
None listed