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NCT07369362 · ClinicalTrials.gov registry record · NA
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.
A NA study of Infertility and Male Infertility, sponsored by MotilityCount aps.
- Active
- Registry status
- NA
- Development phase
- 1,600
- Enrollment target
- 1
- Study location
NCT07369362 is a NA study of Infertility and Male Infertility that is active but no longer recruiting, run by MotilityCount aps. The registered enrollment target is 1,600 participants, below the 7,568-participant average among 74 other Infertility trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07369362, a NA study of Infertility and Male Infertility, is active but no longer recruiting, sponsored by MotilityCount aps.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,600 participants
- Enrollment target
- 1
- Study location
Study 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 retr
Conditions Studied
Interventions
- DEVICE microfludics semen processing device
Study Locations (1)
Connecticut
- First Fertility - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2027-07-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07369362
The ClinicalTrials.gov registry entry for NCT07369362 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,568-participant average among 74 other Infertility trials with a reported enrollment target (79% lower). The listed sponsor is MotilityCount aps, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Infertility appearing as the primary indexed condition, and to 1 intervention - of which microfludics semen processing device is the first listed.
NCT07369362 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT07369362 about?
NCT07369362 is a clinical study titled "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.". 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...
What is the current status of trial NCT07369362?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,600 participants. The study started on 2026-01-20. Estimated completion is 2027-07-20.
What conditions does trial NCT07369362 study?
This clinical trial studies the following conditions: Infertility, Male Infertility, InVitro Fertilization, Aneuploidy Rate, Euploidy Rate.
What interventions are being tested in trial NCT07369362?
The interventions under investigation include: microfludics semen processing device (DEVICE).
Who is sponsoring clinical trial NCT07369362?
This trial is sponsored by MotilityCount aps, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07369362 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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