Sperm Selection Strategies and Male-Factor Phenotypes in ICSI (ANDRO-ART)
11 de septiembre de 2026 actualizado por: Center for Reproductive Medicine Bocian
Comparative Effectiveness of Conventional ICSI, Hyaluronan-Binding Sperm Selection, and Microfluidic Sperm Selection Across Male-Factor Phenotypes: A Multicentre Retrospective Cohort Study
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.
Descripción general del estudio
Estado
Activo, no reclutando
Intervención / Tratamiento
Descripción detallada
The ANDRO-ART study is a retrospective, multicentre, observational cohort study based on routinely collected clinical and embryological data from ICSI treatment cycles performed across multiple fertility centres. The study compares three sperm-selection strategies used in routine clinical practice: conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
The primary analytical framework will evaluate comparative effectiveness in the overall cohort, followed by prespecified phenotype-specific analyses. Particular attention will be given to male-factor biomarkers, including sperm DNA fragmentation, in order to assess whether the clinical association between sperm-selection strategy and reproductive outcomes differs across biologically defined subgroups.
Outcomes of interest include fertilization, embryo development, clinical pregnancy, pregnancy loss, and cumulative reproductive outcomes evaluated from the source ICSI cycle. Additional analyses may include treatment-by-phenotype interactions, subgroup analyses based on sperm DNA fragmentation categories, and sensitivity analyses designed to address confounding and centre-level heterogeneity.
The study is non-interventional. Patients were not assigned to sperm-selection strategies according to a research protocol; all procedures were performed as part of routine fertility treatment. Historical data will be analysed using predefined eligibility criteria and statistical methods before final data freeze.
Tipo de estudio
De observación
Inscripción (Estimado)
12561
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia, 60-529
- Bocian Fertility Clinic, Poznań
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 20-819
- Bocian Fertility Clinic, Lublin
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 00-193
- Bocian Fertility Clinic, Warsaw Śródmieście
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Polonia, 35-309
- Bocian Fertility Clinic, Rzeszów
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-267
- Bocian Fertility Clinic, Białystok
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polonia, 80-244
- Bocian Fertility Clinic, Gdańsk
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polonia, 40-081
- Bocian Fertility Clinic, Katowice
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polonia, 70-225
- Bocian Fertility Clinic, Szczecin
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polonia, 90-440
- Bocian Fertility Clinic, Łódź
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Świętokrzyskie Voivodeship
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Kielce, Świętokrzyskie Voivodeship, Polonia, 25-435
- Bocian Fertility Clinic, Kielce
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population comprises adult women undergoing ICSI treatment in routine clinical practice across multiple fertility centres.
Eligible source ICSI cycles are retrospectively classified according to the sperm-selection strategy used: conventional ICSI, hyaluronan-binding sperm selection (PICSI), or microfluidic sperm selection.
The primary analysis includes an unselected all-comers population, with prespecified phenotype-specific analyses according to male-factor characteristics, including sperm DNA fragmentation.
Descripción
Inclusion Criteria:
- Adult women undergoing an ICSI source cycle at a participating fertility centre during the study period.
- Source cycles performed using conventional ICSI, hyaluronan-binding sperm selection (PICSI), or microfluidic sperm selection.
- Availability of routinely collected clinical and embryological data sufficient to classify the sperm-selection strategy and evaluate at least one prespecified study outcome.
Exclusion Criteria:
- Cycles not involving ICSI.
- Records with insufficient or internally inconsistent data preventing reliable identification of the source ICSI cycle or sperm-selection strategy.
- Cycles involving combined hyaluronan-binding and microfluidic sperm selection are excluded from the primary three-group comparative analysis and may be evaluated separately in prespecified sensitivity analyses.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Conventional ICSI
ICSI source cycles in which spermatozoa were selected using routine conventional laboratory preparation without hyaluronan-binding or microfluidic sperm selection.
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Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.
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PICSI
ICSI source cycles in which spermatozoa were selected using hyaluronan-binding sperm selection (PICSI) as part of routine clinical practice.
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Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
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Microfluidic Sperm Selection
ICSI source cycles in which spermatozoa were prepared using a microfluidic sperm-selection device (ZyMōt) as part of routine clinical practice.
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Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pregnancy Loss After Clinical Pregnancy
Periodo de tiempo: Up to 22 completed weeks of gestation
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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%.
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Up to 22 completed weeks of gestation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Pregnancy
Periodo de tiempo: Up to 8 weeks after embryo transfer
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Clinical pregnancy following embryo transfer, assessed according to routinely recorded clinical follow-up.
The proportion of embryo transfers resulting in clinical pregnancy will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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Up to 8 weeks after embryo transfer
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Cumulative Clinical Pregnancy per Source ICSI Cycle
Periodo de tiempo: From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
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Occurrence of at least one clinical pregnancy resulting from fresh and/or frozen-thawed embryo transfers derived from the same source ICSI cycle.
The cumulative proportion of source ICSI cycles resulting in at least one clinical pregnancy will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
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Normal Fertilization Rate
Periodo de tiempo: Approximately 16-18 hours after ICSI
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Proportion of mature oocytes (MII) undergoing ICSI that demonstrated normal fertilization, defined by the presence of two pronuclei (2PN).
Normal fertilization rate will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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Approximately 16-18 hours after ICSI
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Blastocyst Development Rate
Periodo de tiempo: From normal fertilization assessment through day 5-7 of embryo culture
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Proportion of normally fertilized oocytes (2PN) developing to the blastocyst stage.
Blastocyst development rate will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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From normal fertilization assessment through day 5-7 of embryo culture
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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No Usable Embryo per Initiated ICSI Cycle
Periodo de tiempo: From ICSI through completion of embryo culture for the source cycle
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Proportion of initiated ICSI source cycles resulting in no embryo considered usable for transfer and/or cryopreservation according to routine laboratory assessment.
The outcome is defined at the source-cycle level as zero usable embryos and will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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From ICSI through completion of embryo culture for the source cycle
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Zero 2PN per Initiated ICSI Cycle
Periodo de tiempo: Approximately 16-18 hours after ICSI
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Proportion of initiated ICSI source cycles in which no normally fertilized oocyte (2PN) was observed after ICSI.
This outcome will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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Approximately 16-18 hours after ICSI
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Przemysław Ciepiela, MD, PhD, Bocian Fertility Clinic
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Ferreira Aderaldo J, da Silva Maranhao K, Ferreira Lanza DC. Does microfluidic sperm selection improve clinical pregnancy and miscarriage outcomes in assisted reproductive treatments? A systematic review and meta-analysis. PLoS One. 2023 Nov 20;18(11):e0292891. doi: 10.1371/journal.pone.0292891. eCollection 2023.
- Gisbert Iranzo A, Cano-Extremera M, Hervas I, Falquet Guillem M, Gil Julia M, Navarro-Gomezlechon A, Pacheco-Rendon RM, Garrido N. Sperm Selection Using Microfluidic Techniques Significantly Decreases Sperm DNA Fragmentation (SDF), Enhancing Reproductive Outcomes: A Systematic Review and Meta-Analysis. Biology (Basel). 2025 Jun 30;14(7):792. doi: 10.3390/biology14070792.
- Kirkman-Brown J, Pavitt S, Khalaf Y, Lewis S, Hooper R, Bhattacharya S, Coomarasamy A, Sharma V, Brison D, Forbes G, West R, Pacey A, Brian K, Cutting R, Bolton V, Miller D. Sperm selection for assisted reproduction by prior hyaluronan binding: the HABSelect RCT. Southampton (UK): NIHR Journals Library; 2019 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK537400/
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de enero de 2020
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ANDRO-ART-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared because the study is based on retrospectively collected multicentre clinical data containing sensitive health information.
Data sharing is additionally subject to institutional governance, data-protection regulations, and restrictions related to the original clinical databases.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .