Actively Recruiting

Phase Not Applicable
Age: 18Years - 41Years
FEMALE
NCT06629766

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

Led by Reproductive Medicine Associates of New Jersey · Updated on 2025-04-17

100

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 41Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing first IVF cycle
  • Planning single embryo transfer
  • Planning preimplantation genetic testing for aneuploidy (PGT-A) of embryos
  • Female partner age between 18 and under 42 years at start of ovarian stimulation cycle
  • Anti-Mullerian Hormone (AMH) level at least 1.2 ng/mL
  • Antral Follicle Count (AFC) at least 8
  • Follicle Stimulating Hormone (FSH) level 12 IU/L or less
  • At least 4 mature eggs (metaphase II oocytes) retrieved at egg collection
  • Intention to transfer the morphologically best quality, chromosomally normal embryo at frozen embryo transfer
Not Eligible

You will not qualify if you...

  • Contraindication to IVF treatment
  • Need for preimplantation genetic testing for single gene disorders, chromosomal translocations, or other detailed genetic analyses
  • Male partner with azoospermia or oligozoospermia (less than 500,000 total motile sperm in recent semen analysis within one year)
  • Use of previously frozen sperm for ICSI
  • Use of donor sperm
  • Male partner with Y-chromosome microdeletion
  • Male partner with any karyotype other than 46,XY
  • Male partner requiring surgically retrieved sperm (testicular or epididymal)
  • Uncorrected hydrosalpinges communicating with the uterus
  • Endometrial insufficiency (prior cycle with endometrial thickness less than 6 mm or persistent endometrial fluid)
  • Use of donor eggs or embryos
  • Use of gestational carriers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

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Research Team

C

Caroline Clinical Research Nurse, BSN, RN

CONTACT

C

Christine Director of Research Operations, MS, BSN, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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