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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство LensHooke 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).
• Процедура Density 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.

Первичные конечные точки

• Clinical Pregnancy Rate [Срок оценки: Within 6 weeks after IUI]

Вторичные конечные точки (1)

• Sperm DNA Fragmentation Index (DFI) [Срок оценки: On the day of intrauterine insemination (IUI)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Chung Shan Medical University Hospital — Taichung

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06956287 · CS1-24198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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