RecruitingNot ApplicableNCT06629766

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


Sponsor

Reproductive Medicine Associates of New Jersey

Enrollment

100 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 41 Years

Inclusion Criteria9

  • 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 Criteria12

  • 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

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Interventions

DEVICEMicrofluidic sperm separation 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

OTHERDensity grade centrifugation

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.


Locations(1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

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NCT06629766


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