To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That Develop to the Point That They Are Able to be Transferred) in IVF Cycles.

Summary

The goal of this prospective, multicenter randomized controlled clinical trial is to evaluate whether the SwimCount Harvester microfluidic sperm preparation device can achieve equivalent or superior clinical outcomes compared to standard sperm preparation methods (density gradient centrifugation and swim-up) in couples undergoing in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A).

The study population includes adult couples (female partner age 21-45 years; male partner age ≥21 years) undergoing IVF with PGT-A who meet minimum semen eligibility criteria on the day of oocyte retrieval: pre-processing volume ≥1mL, sperm concentration ≥1 million/mL, and progressive motility ≥10%. A total of 1,600 patients will be randomized 1:1 across 15-25 high-volume IVF centers to receive either Harvester or the site's predominant standard-of-care sperm preparation method. Patients with surgical sperm retrieval requirements or those currently using SwimCount Harvester as standard of care are excluded.

The main questions it aims to answer are:

Does the SwimCount Harvester demonstrate noninferiority to standard sperm preparation methods on blastocyst utilization rate? The primary endpoint is blastocyst utilization rate, calculated as the number of usable blastocysts (operationalized as biopsied blastocysts per clinic standard operating procedures) divided by the number of normally fertilized oocytes (2PN) at the patient level. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval for the risk difference (Harvester minus standard of care) is greater than -2.0 percentage points, using a site-stratified Mantel-Haenszel analysis. If noninferiority is met, superiority may be reported as supportive evidence when the lower confidence bound exceeds zero.

Does the SwimCount Harvester demonstrate noninferiority to standard sperm preparation methods on the probability of obtaining at least one euploid embryo per retrieval? The key secondary endpoint assesses whether patients have at least one euploid embryo (yes/no) based on PGT-A results from a single blinded reference laboratory (NOVA Genomics). This will be analyzed as a site-stratified Mantel-Haenszel risk difference with a two-sided 95% confidence interval, with an optional noninferiority margin of -2.5 percentage points presented as supportive evidence.

Additional supportive and exploratory questions include:

* How does progressive motility change from pre- to post-preparation with each method? Progressive motility will be summarized descriptively pre- and post-preparation as a supportive laboratory measure without hypothesis testing.
* Do outcomes differ in clinically important subgroups? Pre-specified exploratory analyses will examine advanced maternal age (≥40 years) and severe oligospermia (\<5 million/mL), populations that may derive differential benefit from advanced sperm selection.
* What are the practical implementation considerations? An independent protocol complexity analysis will assess procedural steps, equipment requirements, and standardization benefits by comparing site standard-of-care protocols to the Harvester Instructions for Use.

The study addresses a critical evidence gap by providing multicenter, adequately powered data on whether advanced microfluidic sperm preparation translates into meaningful clinical improvements in IVF success metrics.

Conditions

• Infertility
• Male Infertility
• InVitro Fertilization
• Aneuploidy Rate
• Euploidy Rate

Interventions

DEVICE

microfludics semen processing device

Semen will be processed through this device for patients randomized to the study group arm. It is the only intervention.

Sponsors & Collaborators

• MotilityCount aps

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-20

Primary Completion

2027-03-20

Completion

2027-07-20

FDA Device

Yes

Countries

• United States

Study Locations