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The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Recruiting
Who can join
Ages 18 to 41 · Women
Full eligibility criteria
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
About the study
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.
What is being tested
- Microfluidic sperm separation device (device)
- Density grade centrifugation (other)
Sponsor: Reproductive Medicine Associates of New Jersey · Participants: 100 · Started: Apr 9, 2025
Contact the study team
- Caroline Clinical Research Nurse, BSN, RN · Phone: 973-656-2841
- Christine Director of Research Operations, MS, BSN, RN · Phone: 973-656-2841
Official record on ClinicalTrials.gov — NCT06629766
Locations in the U.S.
| New Jersey | Reproductive Medicine Associates of New Jersey, Basking Ridge |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.