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

NCT06629766 | Recruiting

• 1 other identifier: 2405-BRG-141-KB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

microfluidic; density grade centrifugation; sperm selection; paternal age; sperm DNA fragmentation; Zymot

Outcome Measures

Primary Outcomes (1)

• Blastulation Rate per Mature Oocyte (M2)

  count of blastocyst stage embryos per M2 count

  approximately 1 week post oocyte retrieval procedure

Secondary Outcomes (11)

• Fertilization Rate

  approximately 24 hours post oocyte retrieval procedure

• Blastulation Rate per 2PN

  approximately 1 week post oocyte retrieval procedure

• Blastocyst Morphology using Modified Gardner Scale

  approximately 1 week post oocyte retrieval procedure

• Ploidy rates

  approximately 2 weeks post blastocyst trophectoderm biopsy

• Ongoing pregnancy rate

  6 weeks post embryo transfer

Study Arms (2)

Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device

EXPERIMENTAL

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

Oocytes inseminated by sperm prepared via density grade centrifugation

OTHER

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

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

Also known as: Zymot

Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device

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.

Oocytes inseminated by sperm prepared via density grade centrifugation

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Kassie Bollig, MD, MSCE

  Reproductive Medicine Associates of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Clinical Research Nurse, BSN, RN

CONTACT

973-656-2841; clinicalresearchteam@ivirma.com

Christine Director of Research Operations, MS, BSN, RN

CONTACT

973-656-2841; clinicalresearchteam@ivirma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: April 9, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)