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.

NCT07369362 | Active Not Recruiting DMC FDA Device

• 1 other identifier: #20250195
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SwimCount Harvester; Microfluidic sperm selection; Microfluidic sperm preparation; Density gradient centrifugation; Male factor infertility; Preimplantation genetic testing; Euploidy; Aneuploidy; blastocyst; blastocyst utilization; usable blastocyst; embryo; sperm motility; in vitro fertilization; prospective randomized controlled trial; operational efficiency

Outcome Measures

Primary Outcomes (1)

• Useable Blastocyst Rate

  Percentage of blastocysts cryopreserved per number of fertilized oocytes.

  One week - from the day of oocyte retrieval through the last day of embryo assessment.

Secondary Outcomes (1)

• Number of euploid blasts per cycle

  From the start of an IVF cycle through its completion at 15-28 days.

Study Arms (2)

Control group; standard sperm preparation and selection

NO INTERVENTION

This arm is the control group and patients randomized to this arm of the study will have semen processed according to standard operating procedures.

Study group - microfluidics device for sperm preparation

EXPERIMENTAL

Patients randomized to this arm will have their semen processed using the SpermHarvest device which is an FDA approved microfluidics device for semen processing.

Device: microfludics semen processing device

Interventions

microfludics semen processing device DEVICE

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

Study group - microfluidics device for sperm preparation

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sperm sample available on day of egg retrieval
• Female partner age 21-45 years undergoing IVF with PGT-A
• Male partner age ≥ 21 years
• Pre-processing volume ≥1mL
• Pre-processing sperm concentration ≥1 million/mL
• Pre-processing progressive motility ≥10%
• Signed informed consent from both partners

You may not qualify if:

• Surgical sperm retrieval required
• Current standard of care with the SwimCount Harvester device

Sponsors & Collaborators

• MotilityCount aps: lead

Study Sites (1)

First Fertility

Farmington, Connecticut, 06023, United States

Location

Related Publications (5)

• Donnelly ET, Lewis SE, McNally JA, Thompson W. In vitro fertilization and pregnancy rates: the influence of sperm motility and morphology on IVF outcome. Fertil Steril. 1998 Aug;70(2):305-14. doi: 10.1016/s0015-0282(98)00146-0.

  PMID: 9696226 BACKGROUND

• Gisbert Iranzo A, Cano-Extremera M, Hervas I, Falquet Guillem M, Gil Julia M, Navarro-Gomezlechon A, Pacheco-Rendon RM, Garrido N. Sperm Selection Using Microfluidic Techniques Significantly Decreases Sperm DNA Fragmentation (SDF), Enhancing Reproductive Outcomes: A Systematic Review and Meta-Analysis. Biology (Basel). 2025 Jun 30;14(7):792. doi: 10.3390/biology14070792.

  PMID: 40723352 BACKGROUND

• Nosrati R, Vollmer M, Eamer L, San Gabriel MC, Zeidan K, Zini A, Sinton D. Rapid selection of sperm with high DNA integrity. Lab Chip. 2014 Mar 21;14(6):1142-50. doi: 10.1039/c3lc51254a.

  PMID: 24464038 BACKGROUND

• Quinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239.

  PMID: 30007319 BACKGROUND

• Bartolacci A, Pagliardini L, Makieva S, Salonia A, Papaleo E, Vigano P. Abnormal sperm concentration and motility as well as advanced paternal age compromise early embryonic development but not pregnancy outcomes: a retrospective study of 1266 ICSI cycles. J Assist Reprod Genet. 2018 Oct;35(10):1897-1903. doi: 10.1007/s10815-018-1256-8. Epub 2018 Jul 11.

  PMID: 29995229 BACKGROUND

MeSH Terms

Conditions

Infertility; Infertility, Male; Aneuploidy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 27, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: at the conclusion of the study

Locations

US (1)