Skip to content

Automated Sperm Sample Preparation Protocol

Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03999762
Enrollment
2000
Registered
2019-06-27
Start date
2020-05-29
Completion date
2021-11-30
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

This clinical trial would be directed at determining the effectiveness of an innovative sperm sample preparation protocol for intrauterine insemination (IUI). The goal of the protocol would be to enable clinics not performing IUI to be able to perform IUI without requiring specialized training in sperm sample preparation.

Detailed description

Nanonc proposes an automated system for sperm sample preparation that will take in raw ejaculate and output a purified sperm population in an IUI syringe in less than 15 minutes. The IUI syringe will be detachable from the rest of the system. During the 15 minutes, the clinician will not need to perform any actions; as the system will run all of the sample processing steps in an automated fashion. Furthermore, the system will have a footprint of a small desktop printer that is portable to be conveniently placed on a bench in clinical setting. A portable system that performs automated isolation of sperm from ejaculate will revolutionize sperm processing and increase access to sperm sample preparation. Additionally, the system will decrease cost, time and skill required to process sperm, and potentially improve outcomes for patients with low sperm counts. By increasing the yield and precision of sperm isolation and concentration techniques, the investigator's approach has the potential to offer this exact benefit by specifically providing the opportunity for some patients to try less invasive and less expensive procedures.

Interventions

DEVICEsample prep

Effectiveness of a sample preparation protocol

Sponsors

University of Utah
CollaboratorOTHER
Nanonc Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Any couple with doctor's order for IUI with density gradient centrifugation

Exclusion criteria

* Azoospermia

Design outcomes

Primary

MeasureTime frameDescription
Total motile sperm countAt the time of sperm preparationTotal number of progressively motile sperm following sperm preparation
Percentage of patients with positive chemical pregnancy in each study group following IUI2 weeks after IUIDetection of hCG
Percentage of patients with positive clinical pregnancy in each study group following IUI6 to 7 weeks after IUIDetection of the fetal heartbeat by ultrasound

Contacts

Primary ContactKenneth Aston, PhD
kiaston@utah.edu4357640911
Backup ContactTimothy Jenkins, PhD
tim.jenkins@hsc.utah.edu8018855722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026