SwimCount Harvester for Male Infertility in IVF

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: MotilityCount aps
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the SwimCount Harvester to determine if it can improve sperm preparation for couples undergoing IVF (in vitro fertilization) compared to standard methods. The researchers aim to discover if this device can help create more usable embryos and increase the chances of successfully having a healthy baby. Couples suitable for this trial are those undergoing IVF with genetic testing, where the male partner has a sperm concentration of at least 1 million per milliliter and sperm movement above 10%. The study will compare outcomes between those using the new device and those using traditional sperm preparation methods. As an unphased trial, this study offers couples the chance to contribute to innovative fertility research that could enhance IVF success rates.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SwimCount Harvester device is safe for sperm preparation in IVF?

Research shows that the SwimCount Harvester device is safe for preparing sperm. It has received FDA 510(k) clearance, confirming its safe and effective use in the U.S. This approval strongly suggests its safety. The device is easy to use and designed with safety in mind, indicating user comfort.

The available data reports no specific negative effects, supporting the device's safety for its intended purpose. Although detailed information on side effects for this specific trial is unavailable, the FDA approval and absence of reported problems are reassuring for those considering participation in a trial using the SwimCount Harvester.12345

Why are researchers excited about this trial?

Researchers are excited about the SwimCount Harvester for male infertility in IVF because it introduces a cutting-edge microfluidics device for sperm preparation. Unlike traditional methods that rely on centrifugation or swim-up techniques, this device uses microfluidics to precisely select and prepare sperm. This approach can potentially improve the quality and selection of sperm used in IVF, which could lead to higher success rates in fertility treatments. The promise of more efficient and effective sperm preparation is what makes this trial particularly intriguing.

What evidence suggests that the SwimCount Harvester is effective for male infertility in IVF?

Research shows that the SwimCount Harvester, a device used to prepare sperm, can improve sperm quality in several ways. In this trial, participants in the study group will have their semen processed using the SwimCount Harvester. Studies have shown that this device significantly increases the number of sperm that move correctly, an important factor for higher chances of fertilization. The device also consistently produces more early-stage embryos with better shape and structure compared to standard methods. Additionally, it improves sperm concentration and DNA quality, which are key for successful IVF outcomes. These findings suggest that the SwimCount Harvester can potentially increase IVF success rates by selecting healthier sperm. Meanwhile, the control group will have semen processed according to standard operating procedures.36789

Are You a Good Fit for This Trial?

Couples undergoing IVF with PGT-A can join this trial if the male partner has a sperm volume ≥1mL, concentration ≥1 million/mL, and progressive motility ≥10% on retrieval day. The female must be aged 21-45 years. Both partners need to consent.

Inclusion Criteria

My sperm move normally.
I will have a sperm sample available on the day of egg retrieval.
My partner and I have both signed the informed consent.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sperm preparation and IVF cycle with PGT-A testing

4 weeks
Multiple visits for oocyte retrieval and embryo assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Harvester

Trial Overview

The trial is testing if the SwimCount Harvester device for preparing sperm is as good or better than standard methods in helping fertilized eggs develop into blastocysts ready for transfer during IVF cycles.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Study group - microfluidics device for sperm preparationExperimental Treatment1 Intervention
Group II: Control group; standard sperm preparation and selectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MotilityCount aps

Lead Sponsor

Citations

To Investigate if the Harvester® Improves Sperm Motility ...

The study addresses a critical evidence gap by providing multicenter, adequately powered data on whether advanced microfluidic sperm preparation ...

Novel sperm selection device on the basis of microfluidics ...

Primary outcomes included fertilization rate, usable blastocyst rate, good-quality blastocyst rate, euploidy rate, embryo morphokinetics, and AI score to ...

Can Microfluidics Improve Sperm Quality? A Prospective ...

Our results show that the use of the SwimCountTM Harvester resulted in a significant increase in total progressive motile sperm count compared ...

Should we go with the flow? Rethinking sperm selection ...

The results were consistent: the SCH group produced more usable blastocysts, better morphology, and faster morphokinetics. As expected, sperm ...

Latest Research Confirms the SwimCount® Harvester ...

After preparation, SwimCount® Harvester showed significantly better sperm motility, concentration, and total motile sperm count than ZyMōt®, and superior DNA ...

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swimcountharvester.com

swimcountharvester.com/home/

Home Swimcountharvester INT

The SwimCount™ Harvester combines MotilityCount ApS' patented technology with intuitive design, taking sperm preparation into a very safe and user friendly ...

K241348 - Jacob Møllenbach - accessdata.fda.gov

The SwimCount® Harvester (1 mL and 3 mL) is a sperm separation device used to prepare sperm samples for Assisted Reproductive Technology (ART) ...

Improving IVF, ICSI and IUI treatment results with the ...

The SwimCount™ Harvester combines MotilityCount ApS' patented technology with intuitive design, taking sperm preparation into a very safe and user-friendly ...

Revolutionizing Sperm Preparation: Introducing the ...

The SwimCount® Harvester received FDA 510(k) clearance in January 2025, affirming its safety and effectiveness for clinical use in the United States. It is now ...