Male InfertilityNCT03960229
The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor
A study testing MicroFluidic Sperm Sorting Chips and Gradient-Density Centrifugation in people with Male Infertility and Infertility, Male, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF (in vitro fertilization) laboratories leads to the increase of reactive… Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility, Infertility, Male
- What is being tested?
- MicroFluidic Sperm Sorting Chips and Gradient-Density Centrifugation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 23 May 2019to 23 Sep 2019
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apply to the IVF clinic due to male factor
- Volunteer
Who cannot join
- Inadequate follicle development with medication
- Embryo does not have the appropriate quality for transfer
- Female-induced infertility
- Refuse to participate in research
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bezmialem University
Istanbul, 34746
Yeditepe University
Istanbul, 34746
About this study
Official title: The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor: a Randomized Controlled Trial
Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF (in vitro fertilization) laboratories leads to the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
Read the detailed description
The increase in male infertility rate due to environmental and physiological conditions leads to an increase in the use of assisted reproductive techniques. Isolation of living and morphologically normal live sperm is an integrated procedure in commonly used IVF / ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although current IVF / ICSI procedures result in a successful pregnancy of around 50%, the process can be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought that the separation of the sperm by centrifugation in the classical gradient density (Percoll) method which is used in the separation of sperm in the IVF Laboratories, causes the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
- Conditions
- Male Infertility, Infertility, Male
- Being tested
- MicroFluidic Sperm Sorting Chips, Gradient-Density Centrifugation
- Keywords
- microfluid chip, gradient-density, IVF, male factor
- 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 Sorting ChipsOther
sperm selection of IVF treatment
Gradient-Density CentrifugationOther
sperm selection of IVF treatment
| Study group | Role | What they receive |
|---|---|---|
| MicroFluidic Sperm Sorting Chips | Experimental | Sperm Sorting microfluidic chips (for ICSI) will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm Receives: Other: MicroFluidic Sperm Sorting Chips |
| gradient-density centrifugation | Active comparator | gradient-density centrifugation technique will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm Receives: Other: Gradient-Density Centrifugation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare microfluid chip and density-gradient methods in terms of IVF success
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level.
Measured: average of 1 year
Compare microfluid chip and density-gradient methods in terms of embryo quality
Embryo morphology will be assessed on day 3 using the standard criteria of the number of blastomeres and extent of fragmentation and blastomere asymmetry. Top quality embryos on day 3 will be designated as embryos with 7-8 cells, ≤10% fragmentation, and symmetric blastomeres. Using these criteria, the rate of top quality embryos will be analyzed.
Measured: average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start23 May 2019
- Primary completion23 Jul 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960229
- Sponsor's protocol ID
- BezmialemVU microchip study
- Status last verified
- Sep 2019
- First submitted
- 5 Dec 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Asghar W, Velasco V, Kingsley JL, Shoukat MS, Shafiee H, Anchan RM, Mutter GL, Tuzel E, Demirci U. Selection of functional human sperm with higher DNA integrity and fewer reactive oxygen species. Adv Healthc Mater. 2014 Oct;3(10):1671-9. doi: 10.1002/adhm.201400058. Epub 2014 Apr 17.
PubMed 24753434Tasoglu S, Safaee H, Zhang X, Kingsley JL, Catalano PN, Gurkan UA, Nureddin A, Kayaalp E, Anchan RM, Maas RL, Tuzel E, Demirci U. Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting. Small. 2013 Oct 25;9(20):3374-84. doi: 10.1002/smll.201300020. Epub 2013 May 16.
PubMed 23677651Nosrati R, Graham PJ, Zhang B, Riordon J, Lagunov A, Hannam TG, Escobedo C, Jarvi K, Sinton D. Microfluidics for sperm analysis and selection. Nat Rev Urol. 2017 Dec;14(12):707-730. doi: 10.1038/nrurol.2017.175. Epub 2017 Oct 31.
PubMed 29089604
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03960229
- Acronym / sponsor ID
- BezmialemVU microchip study
- Conditions
- Male Infertility, Infertility, Male
- Keywords
- microfluid chip, gradient-density, IVF, male factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Yeditepe University Hospital
- Study start
- 23 May 2019 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 23 May 2019 (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.
Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF (in vitro fertilization) laboratories leads to the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
Detailed description
The increase in male infertility rate due to environmental and physiological conditions leads to an increase in the use of assisted reproductive techniques. Isolation of living and morphologically normal live sperm is an integrated procedure in commonly used IVF / ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although current IVF / ICSI procedures result in a successful pregnancy of around 50%, the process can be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought that the separation of the sperm by centrifugation in the classical gradient density (Percoll) method which is used in the separation of sperm in the IVF Laboratories, causes the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroFluidic Sperm Sorting Chips | Experimental | Other: MicroFluidic Sperm Sorting ChipsSperm Sorting microfluidic chips (for ICSI) will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm |
| gradient-density centrifugation | Active comparator | Other: Gradient-Density Centrifugationgradient-density centrifugation technique will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Apply to the IVF clinic due to male factor
- Volunteer
Key exclusion criteria (4 listed)
- Inadequate follicle development with medication
- Embryo does not have the appropriate quality for transfer
- Female-induced infertility
- Refuse to participate in research
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 Sorting Chipssperm selection of IVF treatment | Other | MicroFluidic Sperm Sorting Chips |
| Gradient-Density Centrifugationsperm selection of IVF treatment | Other | gradient-density centrifugation |
Primary outcome
Compare microfluid chip and density-gradient methods in terms of IVF success
Time frame: average of 1 year
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level.
Compare microfluid chip and density-gradient methods in terms of embryo quality
Time frame: average of 1 year
Embryo morphology will be assessed on day 3 using the standard criteria of the number of blastomeres and extent of fragmentation and blastomere asymmetry. Top quality embryos on day 3 will be designated as embryos with 7-8 cells, ≤10% fragmentation, and symmetric blastomeres. Using these criteria, the rate of top quality embryos will be analyzed.
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 24 Sep 2019.
- Background: PubMed 24753434Asghar W, Velasco V, Kingsley JL, Shoukat MS, Shafiee H, Anchan RM, Mutter GL, Tuzel E, Demirci U. Selection of functional human sperm with higher DNA integrity and fewer reactive oxygen species. Adv Healthc Mater. 2014 Oct;3(10):1671-9. doi: 10.1002/adhm.201400058. Epub 2014 Apr 17.
- Background: PubMed 23677651Tasoglu S, Safaee H, Zhang X, Kingsley JL, Catalano PN, Gurkan UA, Nureddin A, Kayaalp E, Anchan RM, Maas RL, Tuzel E, Demirci U. Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting. Small. 2013 Oct 25;9(20):3374-84. doi: 10.1002/smll.201300020. Epub 2013 May 16.
- Background: PubMed 29089604Nosrati R, Graham PJ, Zhang B, Riordon J, Lagunov A, Hannam TG, Escobedo C, Jarvi K, Sinton D. Microfluidics for sperm analysis and selection. Nat Rev Urol. 2017 Dec;14(12):707-730. doi: 10.1038/nrurol.2017.175. Epub 2017 Oct 31.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Chips and Gradient-Density Centrifugation in people with Male Infertility and Infertility, Male, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
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 2 inclusion and 4 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Compare microfluid chip and density-gradient methods in terms of IVF success (time frame: average of 1 year). 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?
On the ClinicalTrials.gov record for NCT03960229, which also lists 3 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 24 Sep 2019.