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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®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Culture Condition | Experimental | Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators. |
|
| Standard Culture Condition | Active Comparator | Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Culture Condition | Procedure | Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | 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. | April 2013 - October 2016 |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation rate | Number of embryos implanted per number of embryos transferred | April 2013 - October 2016 |
| Live birth rate | Number of newborns per pregnancy achieved |
| Measure | Description | Time Frame |
|---|---|---|
| Fecundation rate | April 2013 - October 2016 | |
| Mean number of viable embryos | April 2013 - October 2016 | |
| Blastocyst rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myriam Ruiz, MSc | Vida Recoletas Sevilla | Study Chair |
| Victor Blasco, MSc | Vida Recoletas Sevilla | Study Chair |
| Manuel Fernandez-Sánchez, PhD | Vida Recoletas Sevilla | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Sevilla | Seville | Seville | 41011 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31994003 | Derived | Ruiz M, Santamaria-Lopez E, Blasco V, Hernaez MJ, Caligara C, Pellicer A, Fernandez-Sanchez M, Prados N. Effect of Group Embryo Culture under Low-Oxygen Tension in Benchtop Incubators on Human Embryo Culture: Prospective, Randomized, Controlled Trial. Reprod Sci. 2020 Jul;27(7):1522-1533. doi: 10.1007/s43032-020-00150-5. Epub 2020 Jan 28. |
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| Standard Culture Condition | Procedure | Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators. |
|
| April 2013 - October 2016 |
| April 2013 - October 2016 |
| Mean number of embryos transferred | April 2013 - October 2016 |
| Live Birth rate per embryos transferred | April 2013 - October 2016 |
| Multiple pregnancy rate | April 2013 - October 2016 |
| Clinical miscarriage rate | April 2013 - October 2016 |