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NCT Number: NCT06956287

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

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.

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Key information

Conditions

Infertility Genital Diseases Genital Diseases, Male Infertility, Male Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, Taichung City, 40201, Taiwan

Location status: Recruiting

Location contact

Tsung-Hsien Lee, M.D., Ph.D

CONTACT

[email protected]

+886920823519

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LensHooke CA0

Device

The intervention involves the use of the LensHooke CA0 sperm-wash device, which incorporates filtration and swim-up techniques to isolate motile and morphologically normal sperm with intact DNA integrity. It is used for sperm preparation in intrauterine insemination (IUI) cycles. The device is designed to reduce oxidative stress and facilitate physiological sperm selection, providing a potential improvement over conventional density gradient centrifugation (DGC).

Other names: CA0

Density Gradient Centrifugation (DGC)

Procedure

The control procedure involves the standard density gradient centrifugation (DGC) method, a widely accepted technique for sperm preparation in IUI. Semen samples are processed using commercially available gradient media to isolate progressively motile sperm. This method serves as the comparator to assess the clinical performance of the LensHooke CA0 device.

Other names: Conventional sperm preparation, gradient centrifugation

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: 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 outcomes

  1. Sperm DNA Fragmentation Index (DFI)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Tsung-Hsien Lee, M.D., Ph.D.

CONTACT

[email protected]

+886920823519

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Acronym: IUI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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