Embryo Development Using Two Commercial Single-step Media

Study Overview
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Brief Summary
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This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.

Official Title
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Embryo Development and Utilization Using Two Commercial Single-step Media

Conditions
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Infertility

Intervention / Treatment
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* Other: embryo culture in different single-step media


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 10 oocytes retrieved Exclusion Criteria: frozen oocytes testicular biopsy less than 10 oocytes retrieved older than 40 years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sage 1-step<br>Embryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in Sage 1-step medium for up to six days following oocyte retrieval. | Other: embryo culture in different single-step media<br>* Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.<br>|
| Active Comparator: CSCM<br>Embryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in CSC medium for up to six days following oocyte retrieval. | Other: embryo culture in different single-step media<br>* Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization rates | Utilization = embryos selected for transfer and cryopreservation | 6 days post oocyte retrieval | 
| Blastocyst formation | Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes | 5 days post oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo quality on day 3 |  | 3 days post oocyte retrieval | 
| blastocyst quality on day 5 |  | 5 days post oocyte retrieval | 
| positive pregnancy test |  | 15 days post oocyte retrieval | 
| clinical pregnancy | presence of gestational sac with positive fetal heartbeat | 7 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-step media, embryo development, blastocyst formation, embryo utilization