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Clinical Trials/NCT03999762
NCT03999762UnknownNot Applicable

Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)

Nanonc Inc.0 sites2,000 target enrollmentStarted: May 29, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
2,000
Primary Endpoint
Percentage of patients with positive chemical pregnancy in each study group following IUI

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Azoospermia

Arms & Interventions

Density gradient sample prep

Active Comparator

Standard density gradient sample preparation

Intervention: sample prep (Device)

Automated sample prep

Experimental

Automated experimental sample preparation

Intervention: sample prep (Device)

Outcomes

Primary Outcomes

Percentage of patients with positive chemical pregnancy in each study group following IUI

Time Frame: 2 weeks after IUI

Detection of hCG

Total motile sperm count

Time Frame: At the time of sperm preparation

Total number of progressively motile sperm following sperm preparation

Percentage of patients with positive clinical pregnancy in each study group following IUI

Time Frame: 6 to 7 weeks after IUI

Detection of the fetal heartbeat by ultrasound

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nanonc Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

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