Automated Sperm Sample Preparation Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)

Conditions
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Infertility

Intervention / Treatment
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* Device: sample prep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any couple with doctor's order for IUI with density gradient centrifugation Exclusion Criteria: Azoospermia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Density gradient sample prep<br>Standard density gradient sample preparation | Device: sample prep<br>* Effectiveness of a sample preparation protocol<br>|
| Experimental: Automated sample prep<br>Automated experimental sample preparation | Device: sample prep<br>* Effectiveness of a sample preparation protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |