Automated Sperm Sample Preparation Protocol

Infertility Clinical Trial

Official title:

Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03999762
• Other study ID #: 0619prep
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2019
• Source: Nanonc Inc.
• Contact: Kenneth Aston, PhD
• Phone: 4357640911
• Email: kiaston[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 preparation.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: November 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Azoospermia

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• sample prep
Effectiveness of a sample preparation protocol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nanonc Inc.	University of Utah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total motile sperm count	Total number of progressively motile sperm following sperm preparation	At the time of sperm preparation
Primary	Percentage of patients with positive chemical pregnancy in each study group following IUI	Detection of hCG	2 weeks after IUI
Primary	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