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ACTIVE NOT RECRUITING
NCT07825584

Sperm Selection Strategies and Male-Factor Phenotypes in ICSI

Sponsor: Center for Reproductive Medicine Bocian

View on ClinicalTrials.gov

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

PROCEDURE

Conventional ICSI

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

PROCEDURE

Hyaluronan-Binding Sperm Selection

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

PROCEDURE

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