Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Reproductive Medicine Associates of New Jersey
- Enrollment
- 237
- Locations
- 4
- Primary Endpoint
- Predictive Value of Aneuploidy Screening
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Predictive Value of Aneuploidy Screening
Time Frame: approximately 1 month post clinical outcome
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.