Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study

Abstract Background Infertility affects a significant portion of the global population, with male factor infertility contributing to nearly half of all cases. The success of assisted reproductive technologies (ART), such as in vitro fertilization (IVF), depends on selecting high-quality sperm with o...

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Main Authors: Yulia Michailov, Eden Amsalem, Natalia Umanski, Valeria Tamadaev, Shevach Friedler, Bozhena Saar-Ryss
Format: Article
Language:English
Published: BMC 2025-06-01
Series:Reproductive Biology and Endocrinology
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Online Access:https://doi.org/10.1186/s12958-025-01424-w
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author Yulia Michailov
Eden Amsalem
Natalia Umanski
Valeria Tamadaev
Shevach Friedler
Bozhena Saar-Ryss
author_facet Yulia Michailov
Eden Amsalem
Natalia Umanski
Valeria Tamadaev
Shevach Friedler
Bozhena Saar-Ryss
author_sort Yulia Michailov
collection DOAJ
description Abstract Background Infertility affects a significant portion of the global population, with male factor infertility contributing to nearly half of all cases. The success of assisted reproductive technologies (ART), such as in vitro fertilization (IVF), depends on selecting high-quality sperm with optimal motility, morphology, and DNA integrity. The Q300™ device offers a novel approach for improving sperm selection. Utilizing an advanced optical imaging system, the Q300™ isolates the morphologically compliant sperm cells sperm for injection into the oocytes. This study aims to assess the usability and preliminary clinical outcome of the Q300™ device under “real-life conditions” in a fertility laboratory setting. Methods Preliminary clinical data collected from Barzilai Medical Center with or without using the technology were compared to the Key Performance Indicators (KPI) for ART laboratories according to the Vienna Consensus. Results The data suggest that the Q300™ significantly improved day-3 embryo development, blastulation, and cumulative pregnancy rates. Conclusions By offering a more refined and efficient selection process, the Q300™ has the potential to redefine clinical practice in infertility treatment, providing patients with a higher likelihood of achieving successful outcomes. Trial registration NCT06232720. Date of registration: 15 February 2023. Enrollment of first subject: 20 August 2023. For more information, visit: https://clinicaltrials.gov/study/NCT06232720 .
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spelling doaj-art-51ce775cf3194d2995a23f936e29f8cb2025-08-20T03:45:33ZengBMCReproductive Biology and Endocrinology1477-78272025-06-012311810.1186/s12958-025-01424-wClinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized studyYulia Michailov0Eden Amsalem1Natalia Umanski2Valeria Tamadaev3Shevach Friedler4Bozhena Saar-Ryss5Ben Gurion University of the Negev, Faculty of Health SciencesIVF Unit-Obstetrics and Gynecology Department, Barzilai Medical CenterIVF Unit-Obstetrics and Gynecology Department, Barzilai Medical CenterIVF Unit-Obstetrics and Gynecology Department, Barzilai Medical CenterBen Gurion University of the Negev, Faculty of Health SciencesBen Gurion University of the Negev, Faculty of Health SciencesAbstract Background Infertility affects a significant portion of the global population, with male factor infertility contributing to nearly half of all cases. The success of assisted reproductive technologies (ART), such as in vitro fertilization (IVF), depends on selecting high-quality sperm with optimal motility, morphology, and DNA integrity. The Q300™ device offers a novel approach for improving sperm selection. Utilizing an advanced optical imaging system, the Q300™ isolates the morphologically compliant sperm cells sperm for injection into the oocytes. This study aims to assess the usability and preliminary clinical outcome of the Q300™ device under “real-life conditions” in a fertility laboratory setting. Methods Preliminary clinical data collected from Barzilai Medical Center with or without using the technology were compared to the Key Performance Indicators (KPI) for ART laboratories according to the Vienna Consensus. Results The data suggest that the Q300™ significantly improved day-3 embryo development, blastulation, and cumulative pregnancy rates. Conclusions By offering a more refined and efficient selection process, the Q300™ has the potential to redefine clinical practice in infertility treatment, providing patients with a higher likelihood of achieving successful outcomes. Trial registration NCT06232720. Date of registration: 15 February 2023. Enrollment of first subject: 20 August 2023. For more information, visit: https://clinicaltrials.gov/study/NCT06232720 .https://doi.org/10.1186/s12958-025-01424-wARTOTASperm selectionICSIBlastocyst
spellingShingle Yulia Michailov
Eden Amsalem
Natalia Umanski
Valeria Tamadaev
Shevach Friedler
Bozhena Saar-Ryss
Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study
Reproductive Biology and Endocrinology
ART
OTA
Sperm selection
ICSI
Blastocyst
title Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study
title_full Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study
title_fullStr Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study
title_full_unstemmed Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study
title_short Clinical outcome using the Q300™ device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study
title_sort clinical outcome using the q300™ device in a reproductive laboratory environment an open label non controlled and non randomized study
topic ART
OTA
Sperm selection
ICSI
Blastocyst
url https://doi.org/10.1186/s12958-025-01424-w
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