Health TrialsbyHealthPanel

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

ConditionsInfertility (IVF Patients)Oocyte CompetenceSperm DNA FragmentationPaternal AgeSperm Selection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-41
SponsorReproductive Medicine Associates of New Jersey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation deviceExperimental treatment 1 intervention
Group B: Oocytes inseminated by sperm prepared via density grade centrifugationOther 1 intervention

Trial outcomes

Primary outcomes

1

Blastulation Rate per Mature Oocyte (M2)

count of blastocyst stage embryos per M2 count

Time frame
approximately 1 week post oocyte retrieval procedure

Secondary outcomes

1

Fertilization Rate

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

Time frame
approximately 24 hours post oocyte retrieval procedure
2

Blastulation Rate per 2PN

count of blastocyst stage embryos per 2PN

Time frame
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.

Time frame
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

Time frame
approximately 2 weeks post blastocyst trophectoderm biopsy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Reproductive Medicine Associates of New Jersey

Lead sponsor

Source ClinicalTrials.gov
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