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

Phase

N/A

Condition

Infertility

Hypogonadism

Men's Health

Treatment

LensHooke CA0

Density Gradient Centrifugation (DGC)

Clinical Study ID

NCT06956287

CS1-24198

Ages 25-50
Male

Study 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.

Eligibility Criteria

Inclusion

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 motilesperm count >40 million after wash.
Willingness of both partners to participate and provide informed consent.

Exclusion

Exclusion Criteria:

Known female infertility factors requiring assisted reproductive technologies beyondIUI.
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

LensHooke CA0

April 24, 2025

December 31, 2026

Study 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.

Connect with a study center

Chung Shan Medical University Hospital
Taichung, Taichung City 40201
Taiwan
Active - Recruiting

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