InfertilityNCT03999762
Automated Sperm Sample Preparation Protocol
A study testing sample prep in people with Infertility, run by Nanonc Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- sample prep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any couple with doctor's order for IUI with density gradient centrifugation
Who cannot join
- Azoospermia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- sample prep
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample prepDevice
Effectiveness of a sample preparation protocol
| Study group | Role | What they receive |
|---|---|---|
| Density gradient sample prep | Active comparator | Standard density gradient sample preparation Receives: Device: sample prep |
| Automated sample prep | Experimental | Automated experimental sample preparation Receives: Device: sample prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total motile sperm count
Total number of progressively motile sperm following sperm preparation
Measured: At the time of sperm preparation
Percentage of patients with positive chemical pregnancy in each study group following IUI
Detection of hCG
Measured: 2 weeks after IUI
Percentage of patients with positive clinical pregnancy in each study group following IUI
Detection of the fetal heartbeat by ultrasound
Measured: 6 to 7 weeks after IUI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start29 May 2020 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanonc Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Raheel Samuel, PhD, Principal investigator, Nanonc Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999762
- Sponsor's protocol ID
- 0619prep
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)
- ClinicalTrials.gov ID
- NCT03999762
- Acronym / sponsor ID
- 0619prep
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanonc Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Study start
- 29 May 2020 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Density gradient sample prep | Active comparator | Device: sample prepStandard density gradient sample preparation |
| Automated sample prep | Experimental | Device: sample prepAutomated experimental sample preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any couple with doctor's order for IUI with density gradient centrifugation
Key exclusion criteria (1 listed)
- Azoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sample prepEffectiveness of a sample preparation protocol | Device | Automated sample prep, Density gradient sample prep |
Primary outcome
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 chemical pregnancy in each study group following IUI
Time frame: 2 weeks after IUI
Detection of hCG
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raheel Samuel, PhD principal investigator
Nanonc Inc.
Questions about this trial
What is this clinical trial studying?
A study testing sample prep in people with Infertility, run by Nanonc Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Aston, PhD (4357640911, kiaston@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total motile sperm count (time frame: At the time of sperm preparation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.