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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Reproductive Medicine Associates of New Jersey
Study ID
NCT06629766
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 41 Years
Healthy Volunteers
Not accepted

Interventions

  • Microfluidic sperm separation device — 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
  • Density grade centrifugation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 9, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device
    Half of the mature oocytes will be randomly allocated to receive sperm prepared by the microfluidic (Zymot) sperm preparation device. This sperm will be used by the embryologist for the ICSI procedure.
  • Other: Oocytes inseminated by sperm prepared via density grade centrifugation
    The other half of the mature oocytes will be allocated to receive sperm prepared by DGC. This sperm will be used by the embryologist for the ICSI procedure.

Primary Outcome Measure

Blastulation Rate per Mature Oocyte (M2) [ Time Frame: approximately 1 week post oocyte retrieval procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Reproductive Medicine Associates of New JerseyBasking RidgeNew Jersey07920-

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Reproductive Medicine Associates of New Jersey· Basking Ridge, NJ

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