Evaluating the Utility of Implementing Microfluids for Sperm Preparation Compared to Conventional Method of Density Gradient Centrifugation in a PGT-A Program: a Sibling Oocyte Study
NCT ID: NCT07093619
Last Updated: 2025-10-02
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-09-12
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Sperm Source obtained by microfluids
FERTILE Plus
The FERTILE PLUS™ method is a standardized method with an easy-to-follow protocol that is far less dependent on the skill or experience of the embryologist than other methods, such as density gradients. The FERTILE PLUS™ (850 µL) Sperm Sorting Chip is a single-use, flow-free, dual chambered, microfluidic-based sperm sorting device. FERTILE PLUS™ was previously known as Zymot, prior to a name change by the manufacturer. The lower chamber contains a sample inlet and fluid channel separated from the upper collection chamber by a microporous membrane with 8-μm pores, demonstrated as the optimal size for selection of sperm with higher motility and normal morphology \[18\].
Sperm Source obtained by gradients
FERTILE Plus
The FERTILE PLUS™ method is a standardized method with an easy-to-follow protocol that is far less dependent on the skill or experience of the embryologist than other methods, such as density gradients. The FERTILE PLUS™ (850 µL) Sperm Sorting Chip is a single-use, flow-free, dual chambered, microfluidic-based sperm sorting device. FERTILE PLUS™ was previously known as Zymot, prior to a name change by the manufacturer. The lower chamber contains a sample inlet and fluid channel separated from the upper collection chamber by a microporous membrane with 8-μm pores, demonstrated as the optimal size for selection of sperm with higher motility and normal morphology \[18\].
Interventions
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FERTILE Plus
The FERTILE PLUS™ method is a standardized method with an easy-to-follow protocol that is far less dependent on the skill or experience of the embryologist than other methods, such as density gradients. The FERTILE PLUS™ (850 µL) Sperm Sorting Chip is a single-use, flow-free, dual chambered, microfluidic-based sperm sorting device. FERTILE PLUS™ was previously known as Zymot, prior to a name change by the manufacturer. The lower chamber contains a sample inlet and fluid channel separated from the upper collection chamber by a microporous membrane with 8-μm pores, demonstrated as the optimal size for selection of sperm with higher motility and normal morphology \[18\].
Eligibility Criteria
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Inclusion Criteria
2. Women of all ages.
3. All embryo qualities ≥BL3CC at the time of biopsy on day 5, 6 and/or 7.
4. Fresh sperm used from ejaculate with a concentration ≥1 mill/ml and ≥10% motility (A+B).
5. Sperm samples with a minimum of 2 ml.
Exclusion Criteria
* PGT-M cases
* Sperm with \> 1M/ml of round cells
ALL
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Andrea Abdala
Senior Clinical Embryologist
Principal Investigators
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Barbara Lawrenz
Role: STUDY_DIRECTOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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Chinnasamy T, Behr B, Demirci U. Microfuidic sperm sorting device for selection of functional human sperm for IUI application. Fertil Steril. 2016;105:e17-8. https://doi.org/10.1016/j.fertn stert.2015.12.063.
Heydari A, Zabetian Targhi M, Halvaei I, Nosrati R. A novel microfluidic device with parallel channels for sperm separation using spermatozoa intrinsic behaviors. Sci Rep. 2023 Jan 21;13(1):1185. doi: 10.1038/s41598-023-28315-7.
Huang CH, Chen CH, Huang TK, Lu F, Jen Huang JY, Li BR. Design of a gradient-rheotaxis microfluidic chip for sorting of high-quality Sperm with progressive motility. iScience. 2023 Jul 17;26(8):107356. doi: 10.1016/j.isci.2023.107356. eCollection 2023 Aug 18.
Fang Y, Wu R, Lee JM, Chan LHM, Chan KYJ. Microfuidic invitro fertilization technologies: transforming the future of human reproduction. TrAC Trends Anal Chem. 2023;160:116959. https:// doi.org/10.1016/j.trac.2023.116959.
Bastuba M, Cohen M, Bastuba A, Campbell P. Microfluidic sperm separation device dramatically lowers DFI. Fertil Steril. 2020;113(4, Supplement):E44 https://doi.org/10.1016/j.fertnstert.2020.02.096.
Leung ETY, Lee CL, Tian X, Lam KKW, Li RHW, Ng EHY, Yeung WSB, Chiu PCN. Simulating nature in sperm selection for assisted reproduction. Nat Rev Urol. 2022 Jan;19(1):16-36. doi: 10.1038/s41585-021-00530-9. Epub 2021 Nov 5.
Quinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239.
Whitesides GM. The origins and the future of microfluidics. Nature. 2006 Jul 27;442(7101):368-73. doi: 10.1038/nature05058.
Vaughan DA, Sakkas D. Sperm selection methods in the 21st century. Biol Reprod. 2019 Dec 24;101(6):1076-1082. doi: 10.1093/biolre/ioz032.
ESHRE Guideline Group on Good Practice in IVF Labs; De los Santos MJ, Apter S, Coticchio G, Debrock S, Lundin K, Plancha CE, Prados F, Rienzi L, Verheyen G, Woodward B, Vermeulen N. Revised guidelines for good practice in IVF laboratories (2015). Hum Reprod. 2016 Apr;31(4):685-6. doi: 10.1093/humrep/dew016. Epub 2016 Feb 17.
Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clin Biochem. 2018 Dec;62:2-10. doi: 10.1016/j.clinbiochem.2018.03.012. Epub 2018 Mar 16.
CDC. 2016-National Summary Report-Assisted Reproductive Technology; US Department of Health. Human Service: Washington, DC, USA, 2018.
De Munck N, El Khatib I, Abdala A, El-Damen A, Bayram A, Arnanz A, Melado L, Lawrenz B, Fatemi HM. Intracytoplasmic sperm injection is not superior to conventional IVF in couples with non-male factor infertility and preimplantation genetic testing for aneuploidies (PGT-A). Hum Reprod. 2020 Feb 29;35(2):317-327. doi: 10.1093/humrep/deaa002.
Lara-Cerrillo S, Raquel Jimenez Macedo A, Hortal O, Rosado Iglesias C, Lacruz Ruiz T, Carrera J, Garcia Peiro A. Impact of Microfluidic Sperm Sorting on Embryonic Euploidy in Infertile Patients with Sperm DNA Damage: A Retrospective Study. Int J Fertil Steril. 2024 Oct 30;18(4):417-423. doi: 10.22074/ijfs.2024.2007775.1499.
Other Identifiers
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2504-ABU-011-AAb
Identifier Type: -
Identifier Source: org_study_id
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