Automated Sperm Sample Preparation Protocol

Not Applicable

• Conditions: Infertility
• Interventions: Device: sample prep

• Registration Number: NCT03999762
• Lead Sponsor: Nanonc Inc.

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.

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05
• Study Start: 2020-05-29
• Primary Completion: 2021-05-31
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• Azoospermia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Automated sample prep	sample prep	Automated experimental sample preparation
Density gradient sample prep	sample prep	Standard density gradient sample preparation

Primary Outcome Measures

Name	Time	Method
Percentage of patients with positive chemical pregnancy in each study group following IUI	2 weeks after IUI	Detection of hCG
Total motile sperm count	At the time of sperm preparation	Total number of progressively motile sperm following sperm preparation
Percentage of patients with positive clinical pregnancy in each study group following IUI	6 to 7 weeks after IUI	Detection of the fetal heartbeat by ultrasound