PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

Study Overview
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Brief Summary
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A prospective cohort study undergoing ICSI at a private fertility center in Egypt

Detailed Description
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Purpose: To evaluate PGTai results for embryos cultured in sequential versus single step media. Method: Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark). All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.

Official Title
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Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program

Conditions
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Mosaicism, Infertility, Aneuploidy Rate

Intervention / Treatment
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* Other: Single step media
* Other: Sequential media


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age ≤37 years with ≥ 8 mature oocytes Male partner had normal semen parameters according to WHO 2010 PGT-A was done at the blastocyst stage Exclusion Criteria: sperm or oocyte donor severe male factors according to WHO 2010

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single step media<br>Embryos cultured in single step media | Other: Single step media<br>* Usage of single step media in embryo culture<br>|
| Active Comparator: Sequential media<br>Embryos cultured in sequential media | Other: Sequential media<br>* Usage of sequential media in embryo culture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euploidy rate | percentage of euploid embryos/ total genetic tested embryos on blast stage | 5:7 days of intracytoplasmic sperm injection(ICSI) | 
| Mosaicism rate | percentage of mosaic embryos/ total genetic tested embryos on blast stage | 5:7 days of ICSI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes | 16:19 hours of ICSI | 
| Cleavage stage | Percentage of cleaved embryos/ total number of fertilized oocytes | 72 hours of ICSI | 
| High quality of cleaved embryos | High quality D3 embryos according to Gardner's criteria / total cleaved embryos | 72 hours of ICSI | 
| Blast formation rate | Percentage of total blastocysts / Total cleaved embryos | 5:7 days of ICSI | 
| High quality blast rate | Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos. | 5:7 days of ICSI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PGT-A, Mosaicism, Single step media, Sequential media