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Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.
Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.
The current study will include 2 RCTs:
RCT 1: Random allocation of sibling oocytes to compare embryo development and blastocyst formation rates in the two culture media compared.
RCT2: Random allocation of patients in either Global or Origio media, to evaluate pregnancy rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Global | Active Comparator | In vitro embryo culture in single-step medium (Global) |
|
| Origio | Active Comparator | In vitro embryo culture in sequential media (Origio) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Global | Other | Single medium for the culture of embryos from Day1 to Day 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implantation rate per embryo transferred | Number of fetal sacs with positive heart beat at 7 weeks of gestation | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst formation rate | Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval | Day 5 |
| Good quality blastocysts | Good quality blastocysts are considered at least full blastocysts (stage 3 and above) with grade A or grade B inner-cell mass and trophectoderm respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioannis A Sfontouris, PhD | Eugonia | Principal Investigator |
| Trifon G Lainas, PhD | Eugonia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eugonia Assisted Reproduction Unit | Athens | Attica | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18439587 | Background | Sepulveda S, Garcia J, Arriaga E, Diaz J, Noriega-Portella L, Noriega-Hoces L. In vitro development and pregnancy outcomes for human embryos cultured in either a single medium or in a sequential media system. Fertil Steril. 2009 May;91(5):1765-70. doi: 10.1016/j.fertnstert.2008.02.169. Epub 2008 Apr 25. | |
| 23315059 | Background |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Origio | Other | Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist) |
|
|
| Day 5 |
| Positive hCG rates | Pregnancy test as assessed by detection of hCG using blood test | 14 days |
| Ongoing pregnancy rates | Pregnancy reaching 12 weeks of gestation | 12 weeks |
| Early pregnancy loss | Miscarriage per positive hCG test up to 12 weeks of gestation | 12 weeks |
| Clinical pregnancy | Pregnancy reaching 7 weeks of gestation | 7 weeks |
| Basile N, Morbeck D, Garcia-Velasco J, Bronet F, Meseguer M. Type of culture media does not affect embryo kinetics: a time-lapse analysis of sibling oocytes. Hum Reprod. 2013 Mar;28(3):634-41. doi: 10.1093/humrep/des462. Epub 2013 Jan 12. |