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Sperm Selection Strategies and Male-Factor Phenotypes in ICSI
Sponsor: Center for Reproductive Medicine Bocian
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.
Official title: Comparative Effectiveness of Conventional ICSI, Hyaluronan-Binding Sperm Selection, and Microfluidic Sperm Selection Across Male-Factor Phenotypes: A Multicentre Retrospective Cohort Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
12561
Start Date
2020-01-02
Completion Date
2026-09
Last Updated
2026-09-17
Healthy Volunteers
No
Interventions
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.
Locations (10)
Bocian Fertility Clinic, Poznań
Poznan, Greater Poland Voivodeship, Poland
Bocian Fertility Clinic, Lublin
Lublin, Lublin Voivodeship, Poland
Bocian Fertility Clinic, Warsaw Śródmieście
Warsaw, Masovian Voivodeship, Poland
Bocian Fertility Clinic, Rzeszów
Rzeszów, Podkarpackie Voivodeship, Poland
Bocian Fertility Clinic, Białystok
Bialystok, Podlaskie Voivodeship, Poland
Bocian Fertility Clinic, Gdańsk
Gdansk, Pomeranian Voivodeship, Poland
Bocian Fertility Clinic, Katowice
Katowice, Silesian Voivodeship, Poland
Bocian Fertility Clinic, Szczecin
Szczecin, West Pomeranian Voivodeship, Poland
Bocian Fertility Clinic, Łódź
Lodz, Łódź Voivodeship, Poland
Bocian Fertility Clinic, Kielce
Kielce, Świętokrzyskie Voivodeship, Poland