Predictive Value of Embryonic Testing

Study Overview
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Brief Summary
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The primary objective of this study is to determine the predictive value of preimplantation genetic screening (PGS) as a marker of embryonic competence. Secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in assisted reproductive technology (ART) cycles.

Detailed Description
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Patients participating in the study will undergo a routine in vitro fertilization cycle. Trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be analyzed till the clinical outcome has been determined. The single, morphologically best embryo available will be selected for transfer. All clinical and laboratory care is identical to that of which subjects would receive if they were not participating in the study. This includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).

Official Title
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Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles

Conditions
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Infertility

Intervention / Treatment
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* Genetic: Preimplantation Genetic Testing-Aneuploidy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples electing embryonic aneuploidy screening (PGS) Couples electing single embryo transfer Exclusion Criteria: Any prior failed IVF cycle Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid Diagnosis of chronic endometritis Maximum day 3 FSH level of 12 or higher Anti-mullerian hormone level less than 0.5 g/mL, tested within previous year Total basal antral follicle count less than 8 follicles Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) BMI <18.5 or > 35 Personal history of recurrent pregnancy loss (two or more pregnancy losses) Use of oocyte donation Use of gestational carrier Medical condition predisposing patient to high risk pregnancy Use of surgical procedures to obtain sperm Presence of hydrosalpinges that communicate with endometrial cavity Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Preimplantation Genetic Testing-Aneuploidy|trophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive Value of Aneuploidy Screening | Determine confidence intervals that a euploid embryo will implant, an aneuploid embryo will not implant, and the likelihood of mosaic and segmental aneuploid embryos implanting and describe their outcomes. | approximately 1 month post clinical outcome |