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

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.

Study Overview

• Status: Recruiting
• Conditions: Sperm DNA Fragmentation; Infertility (IVF Patients); Oocyte Competence; Sperm Selection; Paternal Age
• Intervention / Treatment: Device: Microfluidic sperm separation device; Other: Density grade centrifugation

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Clinical Research Nurse, BSN, RN; Phone Number: 973-656-2841; Email: clinicalresearchteam@ivirma.com
• Study Contact Backup: Name: Christine Director of Research Operations, MS, BSN, RN; Phone Number: 973-656-2841; Email: clinicalresearchteam@ivirma.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Zymot
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastulation Rate per Mature Oocyte (M2)	count of blastocyst stage embryos per M2 count	approximately 1 week post oocyte retrieval procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization Rate	count of fertilized zygotes (2 pronuclei (2PN)) per M2 count	approximately 24 hours post oocyte retrieval procedure
Blastulation Rate per 2PN	count of blastocyst stage embryos per 2PN	approximately 1 week post oocyte retrieval procedure
Ploidy rates	Rates of whole chromosome negative and positive preimplantation genetic testing for aneuploidy (PGT-A) results per blastocyst	approximately 2 weeks post blastocyst trophectoderm biopsy
Live birth rate	rate of live born infants	approximately 7 months after discharge to obstetrician
Blastocyst Morphology using Modified Gardner Scale	Morphology Grade at time of trophectoderm biopsy and vitrification. Expansion 1-6. Inner cell mass and trophectoderm graded A-D.	approximately 1 week post oocyte retrieval procedure
Ongoing pregnancy rate	rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician	6 weeks post embryo transfer
Pregnancy Loss Rates	a loss of pregnancy (either biochemical or clinical)	1 day to 7 months post positive beta human chorionic gonadotrophin
Sperm DNA Fragmentation	Sperm DNA Fragmentation will be run on remnant samples	approximately 1-3 hours post intracytoplasmic sperm injection procedure
Positive beta human chorionic gonadotrophin (bhcg)	positive pregnancy test with bhcg >5mUI/mL	7-10 days post embryo transfer
Embryological Efficiency	Sperm prep time (Time from embryologist possession of sample to completion of prep procedure and ICSI start), benchtop time, ICSI procedural time	same day as ICSI procedure
Embryology Questionnaire	Gain perspectives from lab personnel related to likeability, ease of use and efficiency between the two devices	upon primary outcome completion in approximately 18 months

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Kassie Bollig, MD, MSCE, Reproductive Medicine Associates of new Jersey

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: sperm selection; sperm DNA fragmentation; microfluidic; density grade centrifugation; paternal age; Zymot
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2405-BRG-141-KB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No