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Automated Sperm Sample Preparation Protocol

N

NanoNC

Status

Unknown

Conditions

Infertility

Treatments

Device: sample prep

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03999762
0619prep

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Azoospermia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

2,000 participants in 2 patient groups

Density gradient sample prep
Active Comparator group
Description:
Standard density gradient sample preparation
Treatment:
Device: sample prep
Automated sample prep
Experimental group
Description:
Automated experimental sample preparation
Treatment:
Device: sample prep

Trial contacts and locations

0

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Central trial contact

Timothy Jenkins, PhD; Kenneth Aston, PhD

Data sourced from clinicaltrials.gov

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