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| Name | Class |
|---|---|
| University of Utah | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Density gradient sample prep | Active Comparator | Standard density gradient sample preparation |
|
| Automated sample prep | Experimental | Automated experimental sample preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sample prep | Device | Effectiveness of a sample preparation protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total motile sperm count | Total number of progressively motile sperm following sperm preparation | At the time of sperm preparation |
| Percentage of patients with positive chemical pregnancy in each study group following IUI | Detection of hCG | 2 weeks after IUI |
| Percentage of patients with positive clinical pregnancy in each study group following IUI | Detection of the fetal heartbeat by ultrasound | 6 to 7 weeks after IUI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Aston, PhD | Contact | 4357640911 | kiaston@utah.edu | |
| Timothy Jenkins, PhD | Contact | 8018855722 | tim.jenkins@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Raheel Samuel, PhD | Nanonc Inc. | Principal Investigator |
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IPD will not be shared with other researchers.
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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