Sperm Selection Strategies and Male-Factor Phenotypes in ICSI (ANDRO-ART)
11 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Aktywny, nie rekrutujący
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
12561
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polska, 60-529
- Bocian Fertility Clinic, Poznań
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, Polska, 20-819
- Bocian Fertility Clinic, Lublin
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polska, 00-193
- Bocian Fertility Clinic, Warsaw Śródmieście
-
-
Podkarpackie Voivodeship
-
Rzeszów, Podkarpackie Voivodeship, Polska, 35-309
- Bocian Fertility Clinic, Rzeszów
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polska, 15-267
- Bocian Fertility Clinic, Białystok
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polska, 80-244
- Bocian Fertility Clinic, Gdańsk
-
-
Silesian Voivodeship
-
Katowice, Silesian Voivodeship, Polska, 40-081
- Bocian Fertility Clinic, Katowice
-
-
West Pomeranian Voivodeship
-
Szczecin, West Pomeranian Voivodeship, Polska, 70-225
- Bocian Fertility Clinic, Szczecin
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polska, 90-440
- Bocian Fertility Clinic, Łódź
-
-
Świętokrzyskie Voivodeship
-
Kielce, Świętokrzyskie Voivodeship, Polska, 25-435
- Bocian Fertility Clinic, Kielce
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Conventional ICSI
ICSI source cycles in which spermatozoa were selected using routine conventional laboratory preparation without hyaluronan-binding or microfluidic sperm selection.
|
Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.
|
|
PICSI
ICSI source cycles in which spermatozoa were selected using hyaluronan-binding sperm selection (PICSI) as part of routine clinical practice.
|
Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
|
|
Microfluidic Sperm Selection
ICSI source cycles in which spermatozoa were prepared using a microfluidic sperm-selection device (ZyMōt) as part of routine clinical practice.
|
Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pregnancy Loss After Clinical Pregnancy
Ramy czasowe: Up to 22 completed weeks of gestation
|
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%.
|
Up to 22 completed weeks of gestation
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Clinical Pregnancy
Ramy czasowe: 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.
|
Up to 8 weeks after embryo transfer
|
|
Cumulative Clinical Pregnancy per Source ICSI Cycle
Ramy czasowe: 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.
|
From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
|
|
Normal Fertilization Rate
Ramy czasowe: Approximately 16-18 hours after ICSI
|
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.
|
Approximately 16-18 hours after ICSI
|
|
Blastocyst Development Rate
Ramy czasowe: From normal fertilization assessment through day 5-7 of embryo culture
|
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.
|
From normal fertilization assessment through day 5-7 of embryo culture
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
No Usable Embryo per Initiated ICSI Cycle
Ramy czasowe: 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.
|
From ICSI through completion of embryo culture for the source cycle
|
|
Zero 2PN per Initiated ICSI Cycle
Ramy czasowe: Approximately 16-18 hours after ICSI
|
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.
|
Approximately 16-18 hours after ICSI
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Przemysław Ciepiela, MD, PhD, Bocian Fertility Clinic
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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/
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
2 stycznia 2020
Zakończenie podstawowe (Szacowany)
1 września 2026
Ukończenie studiów (Szacowany)
1 września 2026
Daty rejestracji na studia
Pierwszy przesłany
6 września 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
11 września 2026
Pierwszy wysłany (Rzeczywisty)
17 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
17 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ANDRO-ART-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .