The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in
| Condition(s) | Infertility (IVF Patients), Oocyte Competence, Sperm DNA Fragmentation, Paternal Age, Sperm Selection |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility. |
| Who can participate | 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 a |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Lead sponsor | Reproductive Medicine Associates of New Jersey |
| Locations | Basking Ridge, New Jersey, United States |
| Start date | 2025-04-09 |
| NCT ID | NCT06629766 |
| Official listing | https://clinicaltrials.gov/study/NCT06629766 |