The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture

In this study, we aim to determine the clinical utility of the Zymot sperm selection methodology for ICSI, while also accounting for paternal age. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of DGC sperm preparation for ICSI versus sperm prepared via Zymot for ICSI. Embryology parameters, ploidy status, DNA fragmentation and clinical pregnancy outcomes will be assessed.

Inclusion criteria

• Undergoing first IVF cycle
• Electing single embryo transfer
• Electing PGT-A of their embryos
• Female partners age <42 years old at start of VOR cycle, but >18 years old.
• AMH ≥ 1.2 ng/mL
• AFC ≥ 8
• FSH ≤ 12IU/L
• At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
• Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure

Exclusion criteria

• Contraindication to IVF
• Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
• Male partner with azoospermia or oligozoospermia (<500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment)
• Planned for previously cryopreserved sperm to be used for ICSI
• Donor sperm
• Male partner with Y-chromosome microdeletion
• Male partner with any Karyotype other than 46,XY
• Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures
• Uncorrected hydrosalpinges that communicate with the endometrial cavity
• Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness <6mm,), or persistent endometrial fluid
• Donor oocyte or embryo cycles
• Gestational carriers