Embryo Culture
Conditions
Keywords
grouped embryo culture, embryo density, low oxygen, benchtop incubator, culture condition
Brief summary
Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Besides, previous studies with embryos from human and other mammals have shown that a high oxygen concentration may have a negative effect on embryo quality due to the generation of reactive oxygen species, which cause oxidative stress. The embryo culture at low oxygen tension is correlated to better success rates in IVF/ICSI treatments. The purpose of this study is to evaluate the combined effect of the embryo group culture and the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments. The specific goal is to compare the embryo group culture in a reduced volume of medium at a low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®), whereas the second condition will be applied using a Heracell incubator (Heraeus®).
Interventions
PROCEDURENew Culture Condition
Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.
PROCEDUREStandard Culture Condition
Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.
Sponsors
Vida Recoletas Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* \<38 years (with own oocytes) / \<45 years (with oocyte donation). * First treatment with own oocytes / any treatment with oocyte donation. * ≥10 oocytes with a diameter of ≥10 mm.
Exclusion criteria
* Diseases that affect endometrial receptivity: endometriosis, hydrosalpinx, ovarian hyperstimulation syndrome, obesity, endocrinopathies, thrombophilia, congenital or acquired uterine anomalies. * Patients under a treatment with genetic preimplantation diagnosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | April 2013 - October 2016 | Confirmed when a gestational sac with heartbeat was observed in the uterus by ultrasound examination, performed 2-3 weeks after the positive result of the beta-hCG pregnancy test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | April 2013 - October 2016 | Number of embryos implanted per number of embryos transferred |
| Live birth rate | April 2013 - October 2016 | Number of newborns per pregnancy achieved |
Other
| Measure | Time frame |
|---|---|
| Mean number of embryos transferred | April 2013 - October 2016 |
| Live Birth rate per embryos transferred | April 2013 - October 2016 |
| Fecundation rate | April 2013 - October 2016 |
| Clinical miscarriage rate | April 2013 - October 2016 |
| Multiple pregnancy rate | April 2013 - October 2016 |
| Mean number of viable embryos | April 2013 - October 2016 |
| Blastocyst rate | April 2013 - October 2016 |
Countries
Spain
Outcome results
None listed