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NCT06629766 | NOT YET RECRUITING | Infertility (IVF Patients)

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

Condition or disease

Infertility (IVF Patients)

Oocyte Competence

Sperm DNA Fragmentation

Paternal Age

Sperm Selection

Intervention/treatment

Microfluidic sperm separation device

Density grade centrifugation

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : QUADRUPLE
Masking Description : Statistician
Primary Purpose : OTHER
Official Title : The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 41 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture

Location Details

NCT06629766

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