Automated Sperm Sample Preparation Protocol

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.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Device: sample prep

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Azoospermia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Density gradient sample prep; Standard density gradient sample preparation	Device: sample prep; Effectiveness of a sample preparation protocol
Experimental: Automated sample prep; Automated experimental sample preparation	Device: sample prep; Effectiveness of a sample preparation protocol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanonc Inc.
• Collaborators: University of Utah
• Investigators: Principal Investigator: Raheel Samuel, PhD, Nanonc Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 29, 2020
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 0619prep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No