InfertilityIUINCT06956287
The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
A study testing LensHooke CA0 and Density Gradient Centrifugation (DGC) in people with Infertility and Male Infertility, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 50 years, men only
- Conditions the study is for
- Infertility, Male Infertility
- What is being tested?
- LensHooke CA0 and Density Gradient Centrifugation (DGC)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung, Taichung City, 40201
Tsung-Hsien Lee, M.D., Ph.D, +886920823519, jackth.lee@gmail.com
About this study
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.
Read the 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.
- Conditions
- Infertility, Male Infertility
- Being tested
- LensHooke CA0, Density Gradient Centrifugation (DGC)
- Keywords
- Infertility, intrauterine insemination (IUI), artificial insemination husband, sperm selection, sperm DNA fragmentation, oxidative stress, fertility treatment, male infertility
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LensHooke CA0Device
Also called 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).
Density Gradient Centrifugation (DGC)Procedure or surgery
Also called Conventional sperm preparation, gradient centrifugation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Density Gradient Centrifugation (DGC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 weeks after IUI
Secondary outcomes (1)
Sperm DNA Fragmentation Index (DFI)
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).
Measured: On the day of intrauterine insemination (IUI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start24 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsung-Hsien Lee, Chung Shan Medical University
- Investigators
- Tsung-Hsien Lee, M.D., Ph.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956287
- Sponsor's protocol ID
- CS1-24198
- Acronym
- IUI
- Status last verified
- May 2025
- First submitted
- 21 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD) due to privacy concerns and the lack of established data-sharing infrastructure for this study.
Publications
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.
PubMed 37300647Osman 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.
PubMed 25530036Yang 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.
PubMed 31555559Duong 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.
PubMed 40135621Wright 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.
PubMed 24745838Wagner 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.
PubMed 29713534Sadeghi MR. Unexplained infertility, the controversial matter in management of infertile couples. J Reprod Infertil. 2015 Jan-Mar;16(1):1-2. No abstract available.
PubMed 25717428Juanpanich 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.
PubMed 35698774Gelbaya 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.
PubMed 25112489Duran 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.
PubMed 12456611
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
- ClinicalTrials.gov ID
- NCT06956287
- Acronym / sponsor ID
- IUI / CS1-24198
- Conditions
- Infertility, Male Infertility
- Keywords
- Infertility, intrauterine insemination (IUI), artificial insemination husband, sperm selection, sperm DNA fragmentation, oxidative stress, fertility treatment, male infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Novel Sperm-Wash Device (CA0) Group | Experimental | Device: LensHooke CA0Participants 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. |
| Conventional DGC Group | Active comparator | Procedure: Density Gradient Centrifugation (DGC)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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LensHooke CA0Also: CA0The 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). | Device | Novel Sperm-Wash Device (CA0) Group |
| Density Gradient Centrifugation (DGC)Also: Conventional sperm preparation, gradient centrifugationThe 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. | Procedure or surgery | Conventional DGC Group |
Primary outcome
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.
1 secondary outcome
Sperm DNA Fragmentation Index (DFI)
Time frame: On the day of intrauterine insemination (IUI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 37300647Hsu 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.
- Background: PubMed 25530036Osman 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.
- Background: PubMed 31555559Yang 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.
- Background: PubMed 40135621Duong 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.
- Background: PubMed 24745838Wright 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.
- Background: PubMed 29713534Wagner 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.
- Background: PubMed 25717428Sadeghi MR. Unexplained infertility, the controversial matter in management of infertile couples. J Reprod Infertil. 2015 Jan-Mar;16(1):1-2. No abstract available.
- Background: PubMed 35698774Juanpanich 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.
- Background: PubMed 25112489Gelbaya 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.
- Background: PubMed 12456611Duran 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.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data (IPD) due to privacy concerns and the lack of established data-sharing infrastructure for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsung-Hsien Lee, M.D., Ph.D. principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LensHooke CA0 and Density Gradient Centrifugation (DGC) in people with Infertility and Male Infertility, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tsung-Hsien Lee, M.D., Ph.D. (+886920823519, jackth.lee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: Within 6 weeks after IUI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956287, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.