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

Description

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.

Conditions

Infertility (IVF Patients), Oocyte Competence, Sperm DNA Fragmentation, Paternal Age, Sperm Selection

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Infertility (IVF Patients)
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey, United States, 07920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 41 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Reproductive Medicine Associates of New Jersey,

Kassie Bollig, MD, MSCE, PRINCIPAL_INVESTIGATOR, Reproductive Medicine Associates of New Jersey

Study Record Dates

2026-12