The goal of this clinical trial is to learn if the LensHooke CA0 device lowers DNA fragmentation in sperm samples compared to a gradient/swim-up technique.
The main questions it aims to answer are:
1. Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up technique? 2. Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique? 3. Is sibling embryo fertilization and development the same? 4. Are pregnancy rates different between the 2 groups?
1 semen sample will be split between the 2 treatment techniques. Half of the partner's egg cohort will be injected via intra-cytoplasmic sperm using sperm processed by one technique and the other half of the cohort will be injected by the sperm processed by the other technique. Both methods will look at DNA fragmentation, concentration, motility, and morphology of the sperm. Both methods will be compared in the resulting embryos looking at fertilization, embryo development and pregnancy rates.
Samples with ≥15 M/mL spermatozoa concentration
Female partner between 18 and 34 years old.
Minimum of 4 fertilized eggs in gradient/swim prep group and 4 fertilized eggs in the Lenshooke prep group for each patient
Samples with <15 M/mL spermatozoa concentration
female partner >35 years old
female patient with recurrent pregnancy loss
female patient with diminished ovarian reserve
Richard Kordus, PhD, HCLD (ABB)
Lead sponsor
Prisma Health-Upstate
Sponsor institution