Automated Sperm Sample Preparation Protocol
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sample prep
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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
NCT ID
NCT03999762
First Posted
June 25, 2019
Last Updated
July 1, 2019
Sponsor
Nanonc Inc.
Collaborators
University of Utah
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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