NCT06629766

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Reproductive Medicine Associates of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-09
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2024-10-08
• Last updated: 2025-04-17

Locations

1 site across 1 country: United States