Infertility
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Eugonia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* \<40 years of age * female infertility patients * at least 10 retrieved oocytes
Exclusion criteria
* 41 years or older * frozen-thawed oocytes/embryos * oocyte donation cycles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate per embryo transferred | 7 weeks | Number of fetal sacs with positive heart beat at 7 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Good quality blastocysts | Day 5 | 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. |
| Positive hCG rates | 14 days | Pregnancy test as assessed by detection of hCG using blood test |
| Blastocyst formation rate | Day 5 | Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval |
| Early pregnancy loss | 12 weeks | Miscarriage per positive hCG test up to 12 weeks of gestation |
| Clinical pregnancy | 7 weeks | Pregnancy reaching 7 weeks of gestation |
| Ongoing pregnancy rates | 12 weeks | Pregnancy reaching 12 weeks of gestation |
Countries
Greece
Outcome results
None listed