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

Not Applicable

Not yet recruiting

• Conditions: Semen Analysis; ICSI; PGT-A

• Registration Number: NCT07093619
• Lead Sponsor: ART Fertility Clinics LLC

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.

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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-07-22
• Study Start: 2025-07-30
• Study First Posted: 2025-07-30
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Women with at least 8 MII per cycle after denudation (AFC≥8).
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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of sperm preparation time between microfluidic and gradient methods.	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.	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of post-processing semen parameters between microfluidic and gradient sperm preparation methods	Immediately post-processing	To assess and compare sperm DNA fragmentation index (DFI, %) after preparation using microfluidic and gradient methods from the same sample.
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	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.
Comparison of fertilization rates between sperm processed via microfluidic and gradient methods	Day 1 post-insemination	To evaluate the percentage of metaphase II oocytes successfully fertilized (2PN) using sperm prepared by each method.
Comparison of blastulation and utilization rates of embryos derived from microfluidic vs. gradient sperm preparation	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.
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	To determine whether the distribution of blastocyst biopsy days (Day 5 to Day 7 post-insemination) differs between the two sperm preparation methods.
Comparison of blastocyst morphological quality (expansion) between sperm preparation methods	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.
Mean Time to Key Embryo Developmental Milestones (2-Cell, 4-Cell, Blastocyst) by Sperm Preparation Method	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.
Comparison of blastocyst morphological quality ( inner cell mass - ICM, ) between sperm preparation methods	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.
Comparison of blastocyst trophectoderm quality (TE grades) between sperm preparation methods	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.

Trial Locations

Locations (1)

ART Fertility Clinics LLC; 🇦🇪 Abu Dhabi, United Arab Emirates