Media, Morphokinetics, and Mosaicism

Study Overview
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Brief Summary
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Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.

Official Title
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Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media

Conditions
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Embryonic Mosaicism, Embryo Culture Media, Embryo Morphokinetics, Infertility

Intervention / Treatment
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* Device: EmbryoScope Plus
* Other: GLOBAL MEDIA
* Other: SAGE MEDIA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment. Antral Follicle Count (AFC) >8 Male and female partner > 18 years of age Exclusion Criteria: Female partner age >42 years of age Cleavage stage biopsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: sibling embryo study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SAGE Media<br>SAGE single-step MEDIA | Device: EmbryoScope Plus<br>* All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data<br>Other: SAGE MEDIA<br>* Embryos will be cultured in SAGE media<br>|
| Other: GLOBAL Media<br>LIFE GLOBAL single-step MEDIA | Device: EmbryoScope Plus<br>* All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data<br>Other: GLOBAL MEDIA<br>* Embryos will be cultured in GLOBAL media<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneuploidy Rates | number of embryos with abnormal chromosome number over total number of embryos biopsied (%) | Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo Quality | Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%). | 2 weeks from start of IVF treatment | 
| Embryonic Mosaicism | Fraction of embryos given mosaic diagnosis. Embryonic mosaicism is defined as having partial aneuploidy (20-80% aneuploid). Low-level mosaicism is defined as 20-40% whereas high-level mosaicism is defined as 40-80%. | Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment | 
| Embryo Morphokinetics | time to first and all subsequent cell cleavages | 2 weeks from start of IVF treatment |