Infertility, Male Infertility
Conditions
Keywords
Infertility, intrauterine insemination (IUI), artificial insemination husband, sperm selection, sperm DNA fragmentation, oxidative stress, fertility treatment, male infertility
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.
Interventions
DEVICELensHooke CA0
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).
PROCEDUREDensity Gradient Centrifugation (DGC)
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.
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a two-arm, parallel-design, randomized controlled trial. Participants are randomly assigned to receive either sperm preparation using the novel sperm-wash device (LensHooke® CA0) or conventional density gradient centrifugation.
Eligibility
Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Taiwan
Contacts
Primary ContactTsung-Hsien Lee, M.D., Ph.D.
Outcome results
None listed