The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture

Last updated: April 14, 2025
Sponsor: Reproductive Medicine Associates of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Density grade centrifugation

Microfluidic sperm separation device

Clinical Study ID

NCT06629766
2405-BRG-141-KB
  • Ages 18-41
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 frozenembryo transfer procedure

Exclusion

Exclusion Criteria:

  • Contraindication to IVF

  • Clinical indication for preimplantation genetic testing (i.e., screening for singlegene disorder, chromosomal translocation, or any other disorders requiring a moredetailed embryo genetic analysis)

  • Male partner with azoospermia or oligozoospermia (<500,000 total motile spermatozoaon 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 epididymalretrieval procedures

  • Uncorrected hydrosalpinges that communicate with the endometrial cavity

  • Endometrial Insufficiency, as defined by a prior cycle with maximal endometrialthickness <6mm,), or persistent endometrial fluid

  • Donor oocyte or embryo cycles

  • Gestational carriers

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Density grade centrifugation
Phase:
Study Start date:
April 09, 2025
Estimated Completion Date:
December 31, 2026

Study Description

In this study, we aim to determine the clinical utility of the Zymot sperm selection methodology for ICSI, while also accounting for paternal age. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of DGC sperm preparation for ICSI versus sperm prepared via Zymot for ICSI. Embryology parameters, ploidy status, DNA fragmentation and clinical pregnancy outcomes will be assessed.

Connect with a study center

  • Reproductive Medicine Associates of New Jersey

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.