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Automated Sperm Sample Preparation Protocol

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sample prep
Sponsored by
Nanonc Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Azoospermia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Density gradient sample prep

    Automated sample prep

    Arm Description

    Standard density gradient sample preparation

    Automated experimental sample preparation

    Outcomes

    Primary Outcome Measures

    Total motile sperm count
    Total number of progressively motile sperm following sperm preparation
    Percentage of patients with positive chemical pregnancy in each study group following IUI
    Detection of hCG
    Percentage of patients with positive clinical pregnancy in each study group following IUI
    Detection of the fetal heartbeat by ultrasound

    Secondary Outcome Measures

    Full Information

    First Posted
    June 25, 2019
    Last Updated
    July 1, 2019
    Sponsor
    Nanonc Inc.
    Collaborators
    University of Utah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03999762
    Brief Title
    Automated Sperm Sample Preparation Protocol
    Official Title
    Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 29, 2020 (Anticipated)
    Primary Completion Date
    May 31, 2021 (Anticipated)
    Study Completion Date
    November 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanonc Inc.
    Collaborators
    University of Utah

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Density gradient sample prep
    Arm Type
    Active Comparator
    Arm Description
    Standard density gradient sample preparation
    Arm Title
    Automated sample prep
    Arm Type
    Experimental
    Arm Description
    Automated experimental sample preparation
    Intervention Type
    Device
    Intervention Name(s)
    sample prep
    Intervention Description
    Effectiveness of a sample preparation protocol
    Primary Outcome Measure Information:
    Title
    Total motile sperm count
    Description
    Total number of progressively motile sperm following sperm preparation
    Time Frame
    At the time of sperm preparation
    Title
    Percentage of patients with positive chemical pregnancy in each study group following IUI
    Description
    Detection of hCG
    Time Frame
    2 weeks after IUI
    Title
    Percentage of patients with positive clinical pregnancy in each study group following IUI
    Description
    Detection of the fetal heartbeat by ultrasound
    Time Frame
    6 to 7 weeks after IUI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Any couple with doctor's order for IUI with density gradient centrifugation Exclusion Criteria: Azoospermia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kenneth Aston, PhD
    Phone
    4357640911
    Email
    kiaston@utah.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Timothy Jenkins, PhD
    Phone
    8018855722
    Email
    tim.jenkins@hsc.utah.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raheel Samuel, PhD
    Organizational Affiliation
    Nanonc Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared with other researchers.

    Learn more about this trial

    Automated Sperm Sample Preparation Protocol

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