The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility

Not Applicable

Recruiting

• Conditions: Infertility; Male Infertility

• Registration Number: NCT06956287
• Lead Sponsor: Chung Shan Medical University

Brief Summary

This study evaluates the effectiveness of a novel sperm-wash device designed to improve outcomes in intrauterine insemination (IUI) for couples with infertility. Traditional sperm preparation methods, such as density gradient centrifugation (DGC), are associated with elevated reactive oxygen species (ROS) levels and increased sperm DNA fragmentation, potentially compromising pregnancy rates. The new device aims to reduce these adverse effects by minimizing oxidative stress and preserving sperm DNA integrity.

In this prospective, randomized controlled trial, 120 couples will be allocated to either the intervention group using the new device or the control group using DGC. The primary outcome is the clinical pregnancy rate, while secondary outcomes include sperm DNA fragmentation. The study hypothesizes that the novel device will result in higher pregnancy rates and reduced DNA fragmentation compared to DGC. These findings may support its use as a more physiological approach to sperm preparation in fertility treatment.

Detailed Description

This is a prospective, randomized, open-label, parallel-controlled clinical trial conducted at Chung Shan Medical University Hospital. The study aims to evaluate the clinical efficacy and safety of a novel sperm-wash device-LensHooke CA0-in couples with infertility undergoing intrauterine insemination (IUI). A total of 120 couples will be enrolled and randomly assigned in a 1:1 ratio to the intervention group (LensHooke CA0) or the control group (DGC).

Sperm quality will be evaluated before and after processing, and IUI will be performed following standard clinical procedures. The primary outcome is the clinical pregnancy rate confirmed by ultrasound. The secondary outcome is the sperm DNA fragmentation index (DFI), assessed using the Sperm Chromatin Dispersion (SCD) test.

The study hypothesizes that the novel sperm-wash device will improve pregnancy outcomes and reduce oxidative stress and DNA damage compared to the conventional method. The trial aims to provide supporting evidence for a more physiological and efficient sperm selection strategy in assisted reproduction.

Study Timeline

• Study First Submitted: 2025-04-21
• Study Start: 2025-04-24
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-01
• Study First Posted: 2025-05-04
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• Males aged between 25 to 50 years.
• Part of a couple diagnosed with infertility.
• Undergoing intrauterine insemination (IUI) treatment.
• Sperm concentration >15 million/mL, progressive motility >32%, and total motile sperm count >40 million after wash.
• Willingness of both partners to participate and provide informed consent.

Exclusion Criteria

• Known female infertility factors requiring assisted reproductive technologies beyond IUI.
• Severe male factor infertility (e.g., oligoasthenoteratozoospermia).
• Use of donor sperm or oocyte.
• Chronic illness or medications affecting sperm quality.
• Prior participation in another clinical trial within the past 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	Within 6 weeks after IUI	Defined as the presence of an intrauterine gestational sac with fetal heartbeat confirmed by transvaginal ultrasound after intrauterine insemination (IUI). The outcome aims to evaluate the effectiveness of the novel sperm-wash device (LensHooke CA0) compared to conventional density gradient centrifugation (DGC) in improving clinical pregnancy outcomes following IUI.

Secondary Outcome Measures

Name	Time	Method
Sperm DNA Fragmentation Index (DFI)	On the day of intrauterine insemination (IUI)	The percentage of sperm with fragmented DNA assessed using the Sperm Chromatin Dispersion (SCD) test. This outcome evaluates DNA integrity of sperm processed by the CA0 device compared to conventional density gradient centrifugation (DGC).

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taichung City, Taiwan