Sperm Selection Strategies and Male-Factor Phenotypes in ICSI (ANDRO-ART)
11 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ativo, não recrutando
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Estimado)
12561
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polônia, 60-529
- Bocian Fertility Clinic, Poznań
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polônia, 20-819
- Bocian Fertility Clinic, Lublin
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polônia, 00-193
- Bocian Fertility Clinic, Warsaw Śródmieście
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Polônia, 35-309
- Bocian Fertility Clinic, Rzeszów
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polônia, 15-267
- Bocian Fertility Clinic, Białystok
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polônia, 80-244
- Bocian Fertility Clinic, Gdańsk
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polônia, 40-081
- Bocian Fertility Clinic, Katowice
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polônia, 70-225
- Bocian Fertility Clinic, Szczecin
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polônia, 90-440
- Bocian Fertility Clinic, Łódź
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Świętokrzyskie Voivodeship
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Kielce, Świętokrzyskie Voivodeship, Polônia, 25-435
- Bocian Fertility Clinic, Kielce
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pregnancy Loss After Clinical Pregnancy
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinical Pregnancy
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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No Usable Embryo per Initiated ICSI Cycle
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Przemysław Ciepiela, MD, PhD, Bocian Fertility Clinic
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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/
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de janeiro de 2020
Conclusão Primária (Estimado)
1 de setembro de 2026
Conclusão do estudo (Estimado)
1 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
6 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de setembro de 2026
Primeira postagem (Real)
17 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ANDRO-ART-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .