Sperm Selection Strategies and Male-Factor Phenotypes in ICSI

Condition(s) studied

Investigational drug(s) / intervention(s)

Conventional ICSI: Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.

Hyaluronan-Binding Sperm Selection: Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.

ZyMōt: Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.

Study summary

This retrospective multicentre observational cohort study evaluates clinical and reproductive outcomes associated with different sperm-selection strategies used during intracytoplasmic sperm injection (ICSI), including conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection. The study uses routinely collected real-world clinical and laboratory data from fertility treatment cycles performed at multiple centres. Analyses will assess overall comparative effectiveness and whether treatment effects differ according to male-factor phenotypes, including sperm DNA fragmentation. Key outcomes include fertilization, embryo development, pregnancy establishment, pregnancy loss, and cumulative reproductive outcomes at the source-cycle level. The study is observational; treatment allocation was determined by routine clinical practice rather than by a study protocol.

Eligibility

Primary outcome measure(s)

• Pregnancy Loss After Clinical Pregnancy — Up to 22 completed weeks of gestation
  Pregnancy loss following an established clinical pregnancy. The proportion of clinical pregnancies resulting in pregnancy loss will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection. Prespecified analyses will assess effect modification by sperm DNA fragmentation, including SDF \>20% versus ≤20%.

Trial sites (10)