Male InfertilityMCvsDGCNCT07004309
Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF
A study testing Microfluidic sperm sorting and Density Gradient Centrifugation in people with Male Infertility and Sperm DNA Fragmentation, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
This randomized controlled trial aimed to compare the effectiveness of microfluidic sperm sorting and density gradient centrifugation (DGC) in reducing sperm DNA fragmentation index (DFI) and improving clinical outcomes in IVF. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Male Infertility, Sperm DNA Fragmentation, In Vitro Fertilization (IVF)
- What is being tested?
- Microfluidic sperm sorting and Density Gradient Centrifugation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Mar 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female partner aged between 18 and 40 years
- Couples undergoing in vitro fertilization (IVF) cycles at the IVF and Tissue Engineering Center, Hanoi Medical University, between January 2022 and January 2024
- Use of autologous oocytes
- Use of ejaculated sperm
- Both partners provide written informed consent
Who cannot join
- Use of donor oocytes or donor sperm
- Requirement for testicular sperm extraction
- Diagnosis of oligoasthenozoospermia (OA) based on WHO 2021 criteria
- Female partner classified as having poor ovarian prognosis according to the POSEIDON 2016 criteria, including:
- Anti-Müllerian hormone (AMH) level < 1.2 ng/mL
- Antral follicle count (AFC) < 5
- Or history of poor ovarian response (≤9 oocytes retrieved in previous cycles)
- Preimplantation genetic testing (PGT) cycles
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Center of IVF and Tissue Engineering, Hanoi Medical University Hospital
Hà Nội, 100000
About this study
Official title: Comparative Efficacy of Microfluidics and Density Gradient Centrifugation for Sperm Preparation in IVF: A Randomized Controlled Trial
This randomized controlled trial aimed to compare the effectiveness of microfluidic sperm sorting and density gradient centrifugation (DGC) in reducing sperm DNA fragmentation index (DFI) and improving clinical outcomes in IVF. A total of 119 couples underwent IVF and were assigned to either microfluidic or DGC sperm preparation. The study evaluated sperm quality, fertilization, embryo development, and live birth rates.
Read the detailed description
This single-center randomized controlled trial was conducted at Hanoi Medical University Hospital from March 2023 to March 2024. Couples undergoing IVF were randomized to two sperm preparation methods: microfluidics or density gradient centrifugation. Sperm DNA fragmentation index (DFI) was assessed before and after preparation. Primary outcomes included live birth rate and DFI reduction; secondary outcomes included sperm motility and morphology, fertilization rate, embryo quality, and pregnancy outcomes. The study received IRB approval and adhered to ethical standards.
- Being tested
- Microfluidic sperm sorting, Density Gradient Centrifugation
- Keywords
- Microfluidics, Sperm DNA Fragmentation, In Vitro Fertilization, Sperm Preparation, ICSI
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfluidic sperm sortingProcedure or surgery
Sperm selection using the ZyMot Microfluidic Sperm Separation Device. Process involves loading semen into microfluidic channels to isolate motile sperm with low DNA fragmentation.
Density Gradient CentrifugationProcedure or surgery
Sperm preparation using a discontinuous density gradient technique with SpermGrad and SpermRinse media. Centrifugation separates motile sperm for use in ICSI.
| Study group | Role | What they receive |
|---|---|---|
| Microfluidics Group | Experimental | Semen samples are processed using a microfluidic sperm sorting device (ZyMot). Selected sperm are used for ICSI. Receives: Procedure: Microfluidic sperm sorting |
| DGC Group | Active comparator | Sperm preparation using a discontinuous density gradient method with SpermGrad and SpermRinse media. Receives: Procedure: Density Gradient Centrifugation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm DNA Fragmentation Index (DFI)
DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups
Measured: Day of oocyte retrieval
Live birth rate
Defined as the delivery of a live-born infant after 22 weeks of gestation. Comparison between microfluidics and DGC groups.
Measured: Up to 9 months after embryo transfer
Secondary outcomes (7)
Sperm motility after preparation
Percentage of motile sperm, including both progressive and non-progressive motility, assessed post-preparation using WHO 2021 criteria.
Measured: Immediately after sperm preparation
Normal sperm morphology
Percentage of sperm with normal morphology after preparation, assessed using strict WHO 2021 criteria.
Measured: Immediately after sperm preparation
Fertilization rate
Proportion of injected oocytes showing two pronuclei (2PN).
Measured: 17-20 hours after ICSI
Good-quality embryo rate on Day 2
Percentage of embryos with 4-6 blastomeres and <10% fragmentation on Day 2.
Measured: Day 2 after fertilization
Biochemical pregnancy rate
Defined as serum β-hCG >25 IU/L after embryo transfer.
Measured: 10-12 days after embryo transfer
Clinical pregnancy rate
Presence of gestational sac and fetal heartbeat confirmed on ultrasound.
Measured: 4 weeks after embryo transfer
Ongoing pregnancy rate
Viable intrauterine pregnancy confirmed by ultrasound at 12 weeks.
Measured: 12 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start14 Mar 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male 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
- Participants were randomized into two parallel arms: microfluidic sperm sorting vs. density gradient centrifugation, with equal allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Thuy Huong, Hanoi Medical University
- Investigators
- Do Thuy Huong, PhD candidate, Principal investigator, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004309
- Sponsor's protocol ID
- HU-MCvsDGC-2025
- Acronym
- MCvsDGC
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the sensitive nature of infertility treatment and to protect patient privacy in compliance with institutional ethics guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Microfluidics and Density Gradient Centrifugation for Sperm Preparation in IVF: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07004309
- Acronym / sponsor ID
- MCvsDGC / HU-MCvsDGC-2025
- Keywords
- Microfluidics, Sperm DNA Fragmentation, In Vitro Fertilization, Sperm Preparation, ICSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 4 Jun 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 randomized controlled trial aimed to compare the effectiveness of microfluidic sperm sorting and density gradient centrifugation (DGC) in reducing sperm DNA fragmentation index (DFI) and improving clinical outcomes in IVF. A total of 119 couples underwent IVF and were assigned to either microfluidic or DGC sperm preparation. The study evaluated sperm quality, fertilization, embryo development, and live birth rates.
Detailed description
This single-center randomized controlled trial was conducted at Hanoi Medical University Hospital from March 2023 to March 2024. Couples undergoing IVF were randomized to two sperm preparation methods: microfluidics or density gradient centrifugation. Sperm DNA fragmentation index (DFI) was assessed before and after preparation. Primary outcomes included live birth rate and DFI reduction; secondary outcomes included sperm motility and morphology, fertilization rate, embryo quality, and pregnancy outcomes. The study received IRB approval and adhered to ethical standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized into two parallel arms: microfluidic sperm sorting vs. density gradient centrifugation, with equal allocation.
| Arm | Type | Receives |
|---|---|---|
| Microfluidics Group | Experimental | Procedure: Microfluidic sperm sortingSemen samples are processed using a microfluidic sperm sorting device (ZyMot). Selected sperm are used for ICSI. |
| DGC Group | Active comparator | Procedure: Density Gradient CentrifugationSperm preparation using a discontinuous density gradient method with SpermGrad and SpermRinse media. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female partner aged between 18 and 40 years
- Couples undergoing in vitro fertilization (IVF) cycles at the IVF and Tissue Engineering Center, Hanoi Medical University, between January 2022 and January 2024
- Use of autologous oocytes
- Use of ejaculated sperm
- Both partners provide written informed consent
Key exclusion criteria (8 listed)
- Use of donor oocytes or donor sperm
- Requirement for testicular sperm extraction
- Diagnosis of oligoasthenozoospermia (OA) based on WHO 2021 criteria
- Female partner classified as having poor ovarian prognosis according to the POSEIDON 2016 criteria, including:
- Preimplantation genetic testing (PGT) cycles
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 |
|---|---|---|
| Microfluidic sperm sortingSperm selection using the ZyMot Microfluidic Sperm Separation Device. Process involves loading semen into microfluidic channels to isolate motile sperm with low DNA fragmentation. | Procedure or surgery | Microfluidics Group |
| Density Gradient CentrifugationSperm preparation using a discontinuous density gradient technique with SpermGrad and SpermRinse media. Centrifugation separates motile sperm for use in ICSI. | Procedure or surgery | DGC Group |
Primary outcome
Sperm DNA Fragmentation Index (DFI)
Time frame: Day of oocyte retrieval
DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups
Live birth rate
Time frame: Up to 9 months after embryo transfer
Defined as the delivery of a live-born infant after 22 weeks of gestation. Comparison between microfluidics and DGC groups.
7 secondary outcomes
Sperm motility after preparation
Time frame: Immediately after sperm preparation
Normal sperm morphology
Time frame: Immediately after sperm preparation
Fertilization rate
Time frame: 17-20 hours after ICSI
Good-quality embryo rate on Day 2
Time frame: Day 2 after fertilization
Biochemical pregnancy rate
Time frame: 10-12 days after embryo transfer
Clinical pregnancy rate
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the sensitive nature of infertility treatment and to protect patient privacy in compliance with institutional ethics guidelines.
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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. This study is not recruiting at the moment.
Do Thuy Huong, PhD candidate principal investigator
Hanoi 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 Microfluidic sperm sorting and Density Gradient Centrifugation in people with Male Infertility and Sperm DNA Fragmentation, run by Hanoi Medical University at 1 site in Vietnam.
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 8 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: finished, as of the sponsor's last update on 5 Jun 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm DNA Fragmentation Index (DFI) (time frame: Day of oocyte retrieval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2025.