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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorART Fertility Clinics LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

Frozen oocytes samples with severe oligospermia (≤1mill/ml).

PGT-M cases

Sperm with > 1M/ml of round cells

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 \[18\].

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Sperm Source obtained by microfluidsOther 1 intervention
Group B: Sperm Source obtained by gradientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately post-processing
2

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.

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

Secondary outcomes

1

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.

Time frame
Immediately post-processing
2

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.

Time frame
From enrollment to the end of treatment at 1 year
3

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.

Time frame
Day 1 post-insemination
4

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.

Time frame
Days 5-7 post-insemination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.