Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates

Conditions
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Infertility

Intervention / Treatment
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* Other: Global
* Other: Origio


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Global<br>In vitro embryo culture in single-step medium (Global) | Other: Global<br>* Single medium for the culture of embryos from Day1 to Day 5<br>* Other names: Global medium (LIfeGlobal);|
| Active Comparator: Origio<br>In vitro embryo culture in sequential media (Origio) | Other: Origio<br>* Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)<br>* Other names: ISM1/BlastAssist (Origio);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate per embryo transferred | Number of fetal sacs with positive heart beat at 7 weeks of gestation | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |