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

Reproductive Medicine Associates of New Jersey

Status: Enrolling

Conditions: Paternal Age; Oocyte Competence; Sperm DNA Fragmentation; Infertility (IVF Patients); Sperm Selection

Treatments: Other: Density grade centrifugation; Device: Microfluidic sperm separation device

Study type: Interventional

Funder types: Other

Identifiers

NCT06629766

2405-BRG-141-KB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Microfluidic sperm separation device

Oocytes inseminated by sperm prepared via density grade centrifugation

Other group

Description:

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.

Treatment:

Other: Density grade centrifugation