Sperm Selection Strategies and Male-Factor Phenotypes in ICSI (ANDRO-ART)
11 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Stimato)
12561
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pregnancy Loss After Clinical Pregnancy
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Clinical Pregnancy
Lasso di tempo: Up to 8 weeks after embryo transfer
|
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
Lasso di tempo: From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
|
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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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No Usable Embryo per Initiated ICSI Cycle
Lasso di tempo: From ICSI through completion of embryo culture for the source cycle
|
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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Przemysław Ciepiela, MD, PhD, Bocian Fertility Clinic
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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/
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 gennaio 2020
Completamento primario (Stimato)
1 settembre 2026
Completamento dello studio (Stimato)
1 settembre 2026
Date di iscrizione allo studio
Primo inviato
6 settembre 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 settembre 2026
Primo Inserito (Effettivo)
17 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ANDRO-ART-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .