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

NCT06956287 | Recruiting

• 1 other identifier: CS1-24198
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Male Infertility

Keywords

Infertility; intrauterine insemination (IUI); artificial insemination husband; sperm selection; sperm DNA fragmentation; oxidative stress; fertility treatment; male infertility

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  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.

  Within 6 weeks after IUI

Secondary Outcomes (1)

• Sperm DNA Fragmentation Index (DFI)

  On the day of intrauterine insemination (IUI)

Study Arms (2)

Novel Sperm-Wash Device (CA0) Group

EXPERIMENTAL

Participants in this arm will undergo sperm preparation using the LensHooke CA0 device. The device applies a filtration and swim-up mechanism to select sperm with improved motility, morphology, and DNA integrity, while reducing oxidative stress. The processed sperm will be used for intrauterine insemination (IUI). Outcomes including clinical pregnancy rate, reactive oxygen species (ROS) levels, and sperm DNA fragmentation index (DFI) will be assessed.

Device: LensHooke CA0

Conventional DGC Group

ACTIVE COMPARATOR

Participants in this arm will undergo sperm preparation using the standard density gradient centrifugation (DGC) method. This widely used technique separates motile sperm based on density. The processed sperm will then be used for intrauterine insemination (IUI). The same outcome measures as in the experimental group will be evaluated.

Procedure: Density Gradient Centrifugation (DGC)

Interventions

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).

Also known as: CA0

Novel Sperm-Wash Device (CA0) Group

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.

Also known as: Conventional sperm preparation, gradient centrifugation

Conventional DGC Group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taichung City, 40201, Taiwan

RECRUITING

Related Publications (10)

• Hsu CT, Lee CI, Lin FS, Wang FZ, Chang HC, Wang TE, Huang CC, Tsao HM, Lee MS, Agarwal A. Live motile sperm sorting device for enhanced sperm-fertilization competency: comparative analysis with density-gradient centrifugation and microfluidic sperm sorting. J Assist Reprod Genet. 2023 Aug;40(8):1855-1864. doi: 10.1007/s10815-023-02838-4. Epub 2023 Jun 10.

  PMID: 37300647 BACKGROUND

• Osman A, Alsomait H, Seshadri S, El-Toukhy T, Khalaf Y. The effect of sperm DNA fragmentation on live birth rate after IVF or ICSI: a systematic review and meta-analysis. Reprod Biomed Online. 2015 Feb;30(2):120-7. doi: 10.1016/j.rbmo.2014.10.018. Epub 2014 Nov 13.

  PMID: 25530036 BACKGROUND

• Yang H, Li G, Jin H, Guo Y, Sun Y. The effect of sperm DNA fragmentation index on assisted reproductive technology outcomes and its relationship with semen parameters and lifestyle. Transl Androl Urol. 2019 Aug;8(4):356-365. doi: 10.21037/tau.2019.06.22.

  PMID: 31555559 BACKGROUND

• Duong TND, Dang VQ, Le TK, Vu ATL, Nguyen DL, Pham TD, Nguyen MT, Nguyen PTM, Vo TM, Nguyen CTH, Le PTB, Le AH, Tran CT, Mol BW, Vuong LN, Ho TM. Swim-up versus density gradients for sperm preparation in infertile couples undergoing intrauterine insemination: a randomized clinical trial. Hum Reprod. 2025 May 1;40(5):788-795. doi: 10.1093/humrep/deaf047.

  PMID: 40135621 BACKGROUND

• Wright C, Milne S, Leeson H. Sperm DNA damage caused by oxidative stress: modifiable clinical, lifestyle and nutritional factors in male infertility. Reprod Biomed Online. 2014 Jun;28(6):684-703. doi: 10.1016/j.rbmo.2014.02.004. Epub 2014 Mar 4.

  PMID: 24745838 BACKGROUND

• Wagner H, Cheng JW, Ko EY. Role of reactive oxygen species in male infertility: An updated review of literature. Arab J Urol. 2017 Dec 8;16(1):35-43. doi: 10.1016/j.aju.2017.11.001. eCollection 2018 Mar.

  PMID: 29713534 BACKGROUND

• Sadeghi MR. Unexplained infertility, the controversial matter in management of infertile couples. J Reprod Infertil. 2015 Jan-Mar;16(1):1-2. No abstract available.

  PMID: 25717428 BACKGROUND

• Juanpanich T, Suttirojpattana T, Parnpai R, Vutyavanich T. The relationship between reactive oxygen species, DNA fragmentation, and sperm parameters in human sperm using simplified sucrose vitrification with or without triple antioxidant supplementation. Clin Exp Reprod Med. 2022 Jun;49(2):117-126. doi: 10.5653/cerm.2021.05120. Epub 2022 May 30.

  PMID: 35698774 BACKGROUND

• Gelbaya TA, Potdar N, Jeve YB, Nardo LG. Definition and epidemiology of unexplained infertility. Obstet Gynecol Surv. 2014 Feb;69(2):109-15. doi: 10.1097/OGX.0000000000000043.

  PMID: 25112489 BACKGROUND

• Duran EH, Morshedi M, Taylor S, Oehninger S. Sperm DNA quality predicts intrauterine insemination outcome: a prospective cohort study. Hum Reprod. 2002 Dec;17(12):3122-8. doi: 10.1093/humrep/17.12.3122.

  PMID: 12456611 BACKGROUND

MeSH Terms

Conditions

Infertility; Infertility, Male

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultracentrifugation; Centrifugation; Investigative Techniques; Chemistry Techniques, Analytical

Study Officials

• Tsung-Hsien Lee, M.D., Ph.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+886920823519; jackth.lee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine (M.D.), Doctor of Philosophy (Ph.D.)

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 4, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)