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

NCT06629766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-17

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

Microfluidic sperm separation device

An aliquot of 850ul will be used for the Zymot sperm selection device. The sperm processing via Zymot will be per manufacturer's guidelines

OTHER

Density grade centrifugation

5ul of the ejaculated sample will be assessed for DGC via Makler assessment. If the sample for DGC is adequate per lab standard operating procedures, then routine DGC sperm preparation and embryologist sperm selection for the ICSI procedure will occur.

Sponsors & Collaborators

  • Reproductive Medicine Associates of New Jersey

    lead OTHER

Principal Investigators

  • Kassie Bollig, MD, MSCE · Reproductive Medicine Associates of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2026-01-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629766 on ClinicalTrials.gov