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

ART Fertility Clinics LLC

Status: Enrolling

Conditions: PGT-A; Semen Analysis; ICSI

Treatments: Device: FERTILE Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT07093619

2504-ABU-011-AAb

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Sperm Source obtained by microfluids

Other group

Treatment:

Device: FERTILE Plus

Sperm Source obtained by gradients

Other group

Treatment:

Device: FERTILE Plus