Recruiting

Microfluidics vs. Density Gradient Centrifugation for Sperm Preparation in PGT-A Program

Study Aim

This study compares the time needed and euploidy rates of sperm prepared using microfluidics and density gradient centrifugation for use in PGT-A programs.

What is being tested

FERTILE Plus

Device

Who is being recruted

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorART Fertility Clinics LLC

Study ContactJonalyn Edades, Research CoordinatorMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 12, 2025

Actual date on which the first participant was enrolled.

This study is exploring a new method for preparing sperm in assisted reproductive technology (ART), particularly for couples undergoing a procedure called intracytoplasmic sperm injection (ICSI). The goal is to see if a technique using microfluids can improve sperm selection compared to the traditional method of density gradient centrifugation. Microfluids use small channels that mimic the natural environment of the female reproductive system, aiming to select sperm with better movement and less damage. This could lead to better quality embryos and potentially higher pregnancy success rates, making the process safer and faster. Participants in the study will have their sperm prepared using both the microfluid method and the conventional method. The study will measure the quality of the embryos produced from each method to determine which is more effective. Researchers are interested in whether the microfluid method results in higher euploidy rates, which means having the correct number of chromosomes in an embryo, which is important for successful pregnancies. The potential benefits of this study include improving the chances of pregnancy for couples using ART.

Official TitleEvaluating 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

NCT07093619

Principal SponsorART Fertility Clinics LLC

Study ContactJonalyn Edades, Research CoordinatorMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

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).

Show More Criteria

3 exclusion criteria prevent from participating

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

PGT-M cases

Sperm with > 1M/ml of round cells

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Group II

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

ART Fertility Clinics LLC

Abu Dhabi, United Arab EmiratesOpen ART Fertility Clinics LLC in Google Maps

Recruiting

One Study Center