Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection

In this study, the investigators aim to determine the clinical utility of the ZP-bound sperm selection methodology for ICSI. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of sperm selection for ICSI via the embryologist versus sperm selected via ZP-binding for ICSI. Embryology, ploidy and clinical pregnancy outcomes will be assessed.

Inclusion criteria

• Undergoing their first in vitro fertilization (IVF) cycle
• Electing single embryo transfer
• Electing preimplantation genetic testing for aneuploidy (PGT-A) of their embryos
• Female partners age <42 years old at start of vaginal oocyte retrieval cycle, but >18 years old.
• Normal ovarian reserve:
• Antimullerian hormone level (AMH) ≥ 1.2 ng/mL
• Antral follicle count (AFC) ≥ 8
• At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
• At least 1 immature oocyteretrieved at the VOR procedure to perform ZP binding co-incubation procedure
• 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 (<100,000 total motile spermatozoa)
• 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 cycles
• Gestational carriers