Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-08

Study Completion Date

2022-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. The main questions it aims to answer are:

* Does microfluidic sorting improve pregnancy rate compared to MACS?
* Does microfluidic sorting improve fertilization rate compared to MACS?
* Does microfluidic sorting improve implantation rate compared to MACS?
* Does microfluidic sorting improve blastocyst development rate compared to MACS?

Participants will deposit an eyaculate sample that will be analyzed for DNA fragmentation using a aliquot, then split in two to perform MACS and the microfluidic sorting. Both will be tested for DNA fragmentation (aliquotes) and used for the ICSI treatment with donor oocytes.

Researchers will compare both techniques to see if the selection of the best functional spermatozoa with less DNA fragmentation and clinical outcomes improve.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

NCT03659812

Infertility

COMPLETED NA

Application of MACS and Time-lapse Technology in Good-prognosis Patients

NCT01908569

MACS Technique Efficacy

TERMINATED NA

Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)

NCT03988361

Infertility, Male

UNKNOWN

Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles

NCT04144244

Infertility Unexplained Infertility, Male

UNKNOWN NA

The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor

NCT03960229

Male Infertility Infertility, Male

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In assisted reproductive technology (ART), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. Any type of damage present in sperm DNA can lead to ART failure. Sperm DNA fragmentation might be the most frequent cause of paternal DNA anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. Such DNA fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal DNA integrity as possible from ejaculated semen.

Because of centrifugation steps associated to swim-up or density-gradient can induce sperm DNA fragmentation via reactive oxygen species (ROS), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. It seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. Hence, this new technology has been proposed to minimize DNA damage. In this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower DNA fragmentation spermatozoa when compared to magnetic activated cell sorting (MACS) in split semen samples, and increases clinical outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Male

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental arm

One half of the oocyte cohort is microinjected with sperm selected by the Fertile technique, while the other half of the patient's oocyte cohort is microinjected with sperm selected by the MACS technique.

No interventions assigned to this group