Semen AnalysisNCT07093619
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
A study testing FERTILE Plus in people with Semen Analysis and ICSI, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Semen Analysis, ICSI, PGT-A
- What is being tested?
- FERTILE Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Frozen oocytes samples with severe oligospermia (≤1mill/ml).
- PGT-M cases
- Sperm with > 1M/ml of round cells
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 60202
Jonalyn Edades, Research Coordinator, +97126528000, jonalyn.edades@artfertilityclinics.com
Barbara Lawrenz, Research Director, barbara.lawrenz@artfertilityclinics.com
About this study
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.
Read the detailed description
In assisted reproductive technology (ART), the aim of sperm preparation is to select competent spermatozoa with the highest fertilization potential to be used for insemination by intracytoplasmic sperm injection (ICSI). This makes the process of selecting sperm highly important. Several methods have been developed to mimic some of the natural selection processes that exist in the female reproductive tract. Compared to the conventional sperm preparation techniques such as density gradient or sperm wash, microfluids can select sperm by controlling fluid dynamics within millimeter diameter capillaries in two parallel laminar flow channels, mimicking what potentially sperm experiment in the female genital tract without using centrifuge which can cause DNA sperm fragmentation. Hence, this technique could select spermatozoa with increased motility since motile spermatozoa can move through the flows and be eluted separately, while the debris and immotile cells are passively transported from the entrance to the exit of the capillary canal. There is scientific evidence that for couples undergoing ICSI, the spermatozoa that were selected by using microfluids resulted in a better-quality embryo which leaded to higher pregnancy outcomes. Also, literature suggest that euploidy rates of embryos obtained using microfluids are higher that using conventional sperm sample preparation. Among the advantages that microfluidics certainly offer are, safety, scalability and reduction sperm samples preparation times.
- Conditions
- Semen Analysis, ICSI, PGT-A
- Being tested
- FERTILE Plus
- Keywords
- IVF, Sperm Preparation, euploid, fertilization rate, blastulation rate, morphokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FERTILE PlusDevice
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].
| Study group | Role | What they receive |
|---|---|---|
| Sperm Source obtained by microfluids | Other | Not described Receives: Device: FERTILE Plus |
| Sperm Source obtained by gradients | Other | Not described Receives: Device: FERTILE Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
To assess and compare motility (%) of sperm after preparation using microfluidic and gradient methods from the same sample.
Measured: Immediately post-processing
Comparison of post-treatment semen parameters with pregnancy rates to evaluate the influence of sperm preparation methods on clinical outcomes.
This objective aims to evaluate the correlation between post-treatment semen parameters-including sperm motility (%) measured by computer-assisted semen analysis (CASA), sperm concentration (million/mL) measured by manual counting using a Makler chamber, and morphology (% normal forms) assessed via strict criteria under microscopy-and clinical pregnancy rate (% of patients with confirmed intrauterine pregnancy by ultrasound). The comparison will be made between samples prepared using microfluidic and gradient sperm preparation methods. The goal is to determine whether higher values in semen quality parameters following preparation correlate with increased clinical pregnancy rates, providing quantifiable evidence of each technique's effectiveness in assisted reproductive treatments.
Measured: From enrollment to the end of treatment at 1 year
Comparison of fertilization rates between sperm processed via microfluidic and gradient methods
To evaluate the percentage of metaphase II oocytes successfully fertilized (2PN) using sperm prepared by each method.
Measured: Day 1 post-insemination
Comparison of blastulation and utilization rates of embryos derived from microfluidic vs. gradient sperm preparation
To compare the percentage of embryos reaching the blastocyst stage (blastulation rate) and the percentage of usable blastocysts (utilization rate) between the two sperm preparation methods.
Measured: 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)
To determine whether the distribution of blastocyst biopsy days (Day 5 to Day 7 post-insemination) differs between the two sperm preparation methods.
Measured: Day 5 to Day 7 post-insemination
Comparison of blastocyst morphological quality (expansion) between sperm preparation methods
Comparison of blastocyst expansion grade assessed immediately before biopsy using the modified Gardner scoring system.
Scale: BL1-BL6 BL1: Blastocoel less than half of embryo volume (early blastocyst) BL2: Blastocoel at least half of embryo volume (early blastocyst) BL3: Full blastocyst, blastocoel completely fills embryo BL4: Expanded blastocyst with thin zona pellucida BL5: Herniation of cells through zona pellucida BL6: Blastocyst completely escaped from zona pellucida Interpretation: Higher scores indicate more advanced blastocyst development.
Measured: Day 5-7 post-insemination
Mean Time to Key Embryo Developmental Milestones (2-Cell, 4-Cell, Blastocyst) by Sperm Preparation Method
To compare mean time (in hours post-insemination) for embryos to reach the 2-cell, 4-cell, and blastocyst stages between microfluidic and gradient sperm preparation groups. All timepoints will be reported separately within the same outcome table. Unit of Measure: Hours.
Measured: From fertilization to blastocyst stage (Days 0-7)
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods
To assess and compare sperm concentration (million/mL) after preparation using microfluidic and gradient methods from the same sample.
Measured: Immediately post-processing
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods
To assess and compare sperm morphology (% normal forms), after preparation using microfluidic and gradient methods from the same sample.
Measured: Immediately post-processing
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods
To assess and compare sperm DNA fragmentation index (DFI, %) after preparation using microfluidic and gradient methods from the same sample.
Measured: Immediately post-processing
Comparison of blastocyst morphological quality ( inner cell mass - ICM, ) between sperm preparation methods
Comparison of inner cell mass (ICM) quality using the modified Gardner scoring system, assessed immediately before biopsy.
Scale: A-D A: Numerous tightly packed cells (best quality) B: Several loosely packed cells C: Very few cells D: No cells or >50% degenerated cells Interpretation: Grade A indicates the highest ICM quality.
Measured: Day 5-7 post-insemination
Comparison of blastocyst trophectoderm quality (TE grades) between sperm preparation methods
Description: Comparison of trophectoderm (TE) quality using the modified Gardner scoring system, assessed immediately before biopsy.
Scale: A-D A: Many cells forming a cohesive TE B: Several cells forming a loose epithelium C: Few cells with abnormal disposition D: Very few irregular, necrotic-appearing cells Interpretation: Grade A indicates the highest TE quality.
Measured: Day 5-7 post-insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start12 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Semen AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 50% microfluids group and 50% gradient group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Abdala, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, Study director, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093619
- Sponsor's protocol ID
- 2504-ABU-011-AAb
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: as per request
Publications
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.
PubMed 36681743Huang 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.
PubMed 37559897Fang 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.
PubMed 34741158Quinn 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.
PubMed 30007319Whitesides GM. The origins and the future of microfluidics. Nature. 2006 Jul 27;442(7101):368-73. doi: 10.1038/nature05058.
PubMed 16871203Vaughan DA, Sakkas D. Sperm selection methods in the 21st century. Biol Reprod. 2019 Dec 24;101(6):1076-1082. doi: 10.1093/biolre/ioz032.
PubMed 30801632ESHRE 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.
PubMed 26908842Vander 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.
PubMed 29555319CDC. 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.
PubMed 32086522Lara-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.
PubMed 39564835
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07093619
- Acronym / sponsor ID
- 2504-ABU-011-AAb
- Conditions
- Semen Analysis, ICSI, PGT-A
- Keywords
- IVF, Sperm Preparation, euploid, fertilization rate, blastulation rate, morphokinetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In assisted reproductive technology (ART), the aim of sperm preparation is to select competent spermatozoa with the highest fertilization potential to be used for insemination by intracytoplasmic sperm injection (ICSI). This makes the process of selecting sperm highly important. Several methods have been developed to mimic some of the natural selection processes that exist in the female reproductive tract. Compared to the conventional sperm preparation techniques such as density gradient or sperm wash, microfluids can select sperm by controlling fluid dynamics within millimeter diameter capillaries in two parallel laminar flow channels, mimicking what potentially sperm experiment in the female genital tract without using centrifuge which can cause DNA sperm fragmentation. Hence, this technique could select spermatozoa with increased motility since motile spermatozoa can move through the flows and be eluted separately, while the debris and immotile cells are passively transported from the entrance to the exit of the capillary canal. There is scientific evidence that for couples undergoing ICSI, the spermatozoa that were selected by using microfluids resulted in a better-quality embryo which leaded to higher pregnancy outcomes. Also, literature suggest that euploidy rates of embryos obtained using microfluids are higher that using conventional sperm sample preparation. Among the advantages that microfluidics certainly offer are, safety, scalability and reduction sperm samples preparation times.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50% microfluids group and 50% gradient group
| Arm | Type | Receives |
|---|---|---|
| Sperm Source obtained by microfluids | Other | Device: FERTILE Plus |
| Sperm Source obtained by gradients | Other | Device: FERTILE Plus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Frozen oocytes samples with severe oligospermia (≤1mill/ml).
- PGT-M cases
- Sperm with > 1M/ml of round cells
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FERTILE PlusThe 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]. | Device | Sperm Source obtained by gradients, Sperm Source obtained by microfluids |
Primary outcome
Comparison of sperm preparation time between microfluidic and gradient methods.
Time frame: Immediately post-processing
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.
Comparison of euploidy rates in embryos derived from microfluidic versus gradient-prepared sperm.
Time frame: Up to embryo biopsy (Day 5 or 6 post-fertilization)
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.
12 secondary outcomes
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods
Time frame: Immediately post-processing
Comparison of post-treatment semen parameters with pregnancy rates to evaluate the influence of sperm preparation methods on clinical outcomes.
Time frame: From enrollment to the end of treatment at 1 year
Comparison of fertilization rates between sperm processed via microfluidic and gradient methods
Time frame: Day 1 post-insemination
Comparison of blastulation and utilization rates of embryos derived from microfluidic vs. gradient sperm preparation
Time frame: 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)
Time frame: Day 5 to Day 7 post-insemination
Comparison of blastocyst morphological quality (expansion) between sperm preparation methods
Time frame: Day 5-7 post-insemination
Mean Time to Key Embryo Developmental Milestones (2-Cell, 4-Cell, Blastocyst) by Sperm Preparation Method
Time frame: From fertilization to blastocyst stage (Days 0-7)
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods
Time frame: Immediately post-processing
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods
Time frame: Immediately post-processing
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods
Time frame: Immediately post-processing
Comparison of blastocyst morphological quality ( inner cell mass - ICM, ) between sperm preparation methods
Time frame: Day 5-7 post-insemination
Comparison of blastocyst trophectoderm quality (TE grades) between sperm preparation methods
Time frame: Day 5-7 post-insemination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- BackgroundChinnasamy 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: PubMed 36681743Heydari 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.
- Background: PubMed 37559897Huang 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.
- BackgroundFang 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.
- BackgroundBastuba 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: PubMed 34741158Leung 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.
- Background: PubMed 30007319Quinn 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.
- Background: PubMed 16871203Whitesides GM. The origins and the future of microfluidics. Nature. 2006 Jul 27;442(7101):368-73. doi: 10.1038/nature05058.
- Background: PubMed 30801632Vaughan DA, Sakkas D. Sperm selection methods in the 21st century. Biol Reprod. 2019 Dec 24;101(6):1076-1082. doi: 10.1093/biolre/ioz032.
- Background: PubMed 26908842ESHRE 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.
- Background: PubMed 29555319Vander 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.
- BackgroundCDC. 2016-National Summary Report-Assisted Reproductive Technology; US Department of Health. Human Service: Washington, DC, USA, 2018.
- Individual participant dataSharing planned: Undecided. as per request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Lawrenz study director
ART Fertility Clinics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FERTILE Plus in people with Semen Analysis and ICSI, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonalyn Edades, Research Coordinator (+97126528000, jonalyn.edades@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sperm preparation time between microfluidic and gradient methods. (time frame: Immediately post-processing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07093619, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.