NCT Number: NCT07093619
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.
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Request InfoAll sexes
Interventional
Not applicable
Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates
Location status: Recruiting
Andrea Abdala, embryologist
PRINCIPAL_INVESTIGATOR
Barbara Lawrenz, Research Director
CONTACT
Jonalyn Edades, Research Coordinator
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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].
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.
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.
Time frame: Immediately post-processing
To assess and compare motility (%) of sperm after preparation using microfluidic and gradient methods from the same sample.
Time frame: From enrollment to the end of treatment at 1 year
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.
Time frame: Day 1 post-insemination
To evaluate the percentage of metaphase II oocytes successfully fertilized (2PN) using sperm prepared by each method.
Time frame: Days 5-7 post-insemination
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.
Time frame: Day 5 to Day 7 post-insemination
To determine whether the distribution of blastocyst biopsy days (Day 5 to Day 7 post-insemination) differs between the two sperm preparation methods.
Time frame: Day 5-7 post-insemination
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.
Time frame: From fertilization to blastocyst stage (Days 0-7)
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.
Time frame: Immediately post-processing
To assess and compare sperm concentration (million/mL) after preparation using microfluidic and gradient methods from the same sample.
Time frame: Immediately post-processing
To assess and compare sperm morphology (% normal forms), after preparation using microfluidic and gradient methods from the same sample.
Time frame: Immediately post-processing
To assess and compare sperm DNA fragmentation index (DFI, %) after preparation using microfluidic and gradient methods from the same sample.
Time frame: Day 5-7 post-insemination
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.
Time frame: Day 5-7 post-insemination
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.
Contact information is provided by the study sponsor or research team.
Barbara Lawrenz, Research Director
CONTACT
Jonalyn Edades, Research Coordinator
CONTACT
ART Fertility Clinics LLC
Other
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