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Infertility (IVF Patients)EPICNCT06629766

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

A study testing Microfluidic sperm separation device and Density grade centrifugation in people with Infertility (IVF Patients) and Oocyte Competence, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 41 years, women only
What is being tested?
Microfluidic sperm separation device and Density grade centrifugation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
9 Apr 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 41 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting

  • Reproductive Medicine Associates of New Jersey

    Basking Ridge, New Jersey, 07920

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Microfluidic sperm separation device, Density grade centrifugation
Keywords
microfluidic, density grade centrifugation, sperm selection, paternal age, sperm DNA fragmentation, Zymot
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microfluidic sperm separation deviceDevice

    Also called Zymot

    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 centrifugationOther

    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 groups in NCT06629766
Study groupRoleWhat they receive
Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation deviceExperimentalHalf 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.
Receives: Device: Microfluidic sperm separation device
Oocytes inseminated by sperm prepared via density grade centrifugationOtherThe 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.
Receives: Other: Density grade centrifugation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blastulation Rate per Mature Oocyte (M2)

    count of blastocyst stage embryos per M2 count

    Measured: approximately 1 week post oocyte retrieval procedure

Secondary outcomes (11)

  1. Fertilization Rate

    count of fertilized zygotes (2 pronuclei (2PN)) per M2 count

    Measured: approximately 24 hours post oocyte retrieval procedure

  2. Blastulation Rate per 2PN

    count of blastocyst stage embryos per 2PN

    Measured: approximately 1 week post oocyte retrieval procedure

  3. 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.

    Measured: approximately 1 week post oocyte retrieval procedure

  4. Ploidy rates

    Rates of whole chromosome negative and positive preimplantation genetic testing for aneuploidy (PGT-A) results per blastocyst

    Measured: approximately 2 weeks post blastocyst trophectoderm biopsy

  5. Ongoing pregnancy rate

    rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician

    Measured: 6 weeks post embryo transfer

  6. Pregnancy Loss Rates

    a loss of pregnancy (either biochemical or clinical)

    Measured: 1 day to 7 months post positive beta human chorionic gonadotrophin

  7. Live birth rate

    rate of live born infants

    Measured: approximately 7 months after discharge to obstetrician

  8. Sperm DNA Fragmentation

    Sperm DNA Fragmentation will be run on remnant samples

    Measured: approximately 1-3 hours post intracytoplasmic sperm injection procedure

  9. Positive beta human chorionic gonadotrophin (bhcg)

    positive pregnancy test with bhcg >5mUI/mL

    Measured: 7-10 days post embryo transfer

  10. Embryological Efficiency

    Sperm prep time (Time from embryologist possession of sample to completion of prep procedure and ICSI start), benchtop time, ICSI procedural time

    Measured: same day as ICSI procedure

  11. Embryology Questionnaire

    Gain perspectives from lab personnel related to likeability, ease of use and efficiency between the two devices

    Measured: upon primary outcome completion in approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start9 Apr 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06629766
Sponsor's protocol ID
2405-BRG-141-KB
Acronym
EPIC
Status last verified
Jun 2026
First submitted
3 Oct 2024
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Microfluidic sperm separation device and Density grade centrifugation in people with Infertility (IVF Patients) and Oocyte Competence, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caroline Clinical Research Nurse, BSN, RN (973-656-2841, clinicalresearchteam@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blastulation Rate per Mature Oocyte (M2) (time frame: approximately 1 week post oocyte retrieval procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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