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Infertility (IVF Patients)FertilityIVF and assisted reproductionDevice

What this study is

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.

What's being tested

  • Microfluidic sperm separation device

    Intervention · 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

    Intervention · OTHER

    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.

Study details

Sponsor
Reproductive Medicine Associates of New Jersey
Conditions
Infertility (IVF Patients) · Oocyte Competence · Sperm DNA Fragmentation · Paternal Age · Sperm Selection
Enrolling
100 people
Starts
2025-04-09
Est. completion
2028-12
Design
Quadruple-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗