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

Not Applicable

Recruiting

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

• Registration Number: NCT06629766
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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.

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 Timeline

• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Status Verified: 2025-04
• Study Start: 2025-04-09
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oocytes inseminated by sperm prepared via density grade centrifugation	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.
Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device	Microfluidic sperm separation 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.

Primary Outcome Measures

Name	Time	Method
Blastulation Rate per Mature Oocyte (M2)	approximately 1 week post oocyte retrieval procedure	count of blastocyst stage embryos per M2 count

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States