Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,000
- Primary Endpoint
- Percentage of patients with positive chemical pregnancy in each study group following IUI
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Any couple with doctor's order for IUI with density gradient centrifugation
Exclusion Criteria
- •Azoospermia
Arms & Interventions
Density gradient sample prep
Standard density gradient sample preparation
Intervention: sample prep (Device)
Automated sample prep
Automated experimental sample preparation
Intervention: sample prep (Device)
Outcomes
Primary Outcomes
Percentage of patients with positive chemical pregnancy in each study group following IUI
Time Frame: 2 weeks after IUI
Detection of hCG
Total motile sperm count
Time Frame: 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
Time Frame: 6 to 7 weeks after IUI
Detection of the fetal heartbeat by ultrasound
Secondary Outcomes
No secondary outcomes reported
