The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Recruiting now · Not applicable
Conditions studied: Infertility (IVF Patients), Oocyte Competence, Sperm DNA Fragmentation, Paternal Age, Sperm Selection
In brief
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.
Key facts
- Study ID
- NCT06629766
- Run by
- Reproductive Medicine Associates of New Jersey
- People needed
- 100
- Starts
- 2025-04-09
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 41. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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