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

NCT07093619 | Recruiting DMC

• 1 other identifier: 2504-ABU-011-AAb
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In assisted reproductive technology (ART), sperm preparation aims to select the most viable sperm for ICSI. Unlike conventional methods like density gradients or sperm washing, microfluidic techniques mimic natural selection in the female reproductive tract by using laminar flow without centrifugation, reducing the risk of DNA damage. This method isolates highly motile sperm while filtering out debris and immotile cells. Studies show that microfluidics improve embryo quality, increase pregnancy rates, and may lead to higher euploidy rates. Additional benefits include improved safety, scalability, and shorter preparation times.

Conditions

Semen Analysis; ICSI; PGT-A

Keywords

IVF; Sperm Preparation; euploid; fertilization rate; blastulation rate; morphokinetics

Outcome Measures

Primary Outcomes (2)

• Comparison of sperm preparation time between microfluidic and gradient methods.

  To evaluate and compare the time (in minutes) required to prepare sperm samples using microfluidic technology versus conventional density gradient centrifugation from the same ejaculate sample.

  Immediately post-processing

• Comparison of euploidy rates in embryos derived from microfluidic versus gradient-prepared sperm.

  To compare the percentage of chromosomally normal (euploid) embryos, as determined by preimplantation genetic testing for aneuploidy (PGT-A), following fertilization using sperm processed via microfluidic versus gradient methods from the same semen sample.

  Up to embryo biopsy (Day 5 or 6 post-fertilization)

Secondary Outcomes (12)

• Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods

  Immediately post-processing

• Comparison of post-treatment semen parameters with pregnancy rates to evaluate the influence of sperm preparation methods on clinical outcomes.

  From enrollment to the end of treatment at 1 year

• Comparison of fertilization rates between sperm processed via microfluidic and gradient methods

  Day 1 post-insemination

• Comparison of blastulation and utilization rates of embryos derived from microfluidic vs. gradient sperm preparation

  Days 5-7 post-insemination

• Number of Participants with Blastocyst Biopsy on Day 5, Day 6, or Day 7 by Sperm Preparation Method (Microfluidic vs. Gradient)

  Day 5 to Day 7 post-insemination

Study Arms (2)

Sperm Source obtained by microfluids

OTHER

Device: FERTILE Plus

Sperm Source obtained by gradients

OTHER

Device: FERTILE Plus

Interventions

FERTILE Plus DEVICE

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; Sperm Source obtained by microfluids

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with at least 8 MII per cycle after denudation (AFC≥8).
• Women of all ages.
• All embryo qualities ≥BL3CC at the time of biopsy on day 5, 6 and/or 7.
• Fresh sperm used from ejaculate with a concentration ≥1 mill/ml and ≥10% motility (A+B).
• Sperm samples with a minimum of 2 ml.

You may not qualify if:

• Frozen oocytes samples with severe oligospermia (≤1mill/ml).
• PGT-M cases
• Sperm with \> 1M/ml of round cells

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  PMID: 36681743 BACKGROUND

• 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.

  PMID: 37559897 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34741158 BACKGROUND

• 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.

  PMID: 30007319 BACKGROUND

• Whitesides GM. The origins and the future of microfluidics. Nature. 2006 Jul 27;442(7101):368-73. doi: 10.1038/nature05058.

  PMID: 16871203 BACKGROUND

• 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.

  PMID: 30801632 BACKGROUND

• 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.

  PMID: 26908842 BACKGROUND

• 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.

  PMID: 29555319 BACKGROUND

• CDC. 2016-National Summary Report-Assisted Reproductive Technology; US Department of Health. Human Service: Washington, DC, USA, 2018.

  BACKGROUND

• 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.

  PMID: 32086522 BACKGROUND

• 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.

  PMID: 39564835 BACKGROUND

Study Officials

• Barbara Lawrenz

  ART Fertility Clinics LLC

  STUDY DIRECTOR

Central Study Contacts

Jonalyn Edades, Research Coordinator

CONTACT

+97126528000; jonalyn.edades@artfertilityclinics.com

Barbara Lawrenz, Research Director

CONTACT

+97126528000; barbara.lawrenz@artfertilityclinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Embryologist

Model Details: 50% microfluids group and 50% gradient group

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 30, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-06

Locations

AE (1)