Infertility UnexplainedNCT04144244
Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles
A study testing MicroFluidic Sperm Sorting Chips and Gradient-Density Centrifugation in people with Infertility Unexplained and Infertility, Male, run by Bezmialem Vakif University at 1 site 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 and IUI cycles leads to the increase of reactive oxygen radicals in… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Unexplained, 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
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2019to 15 Jul 2020
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count >5 million)
- Volunteer
Who cannot join
- Inadequate follicle development with medication
- Embryo does not have the appropriate quality for transfer
- Tubal pathology
- Total motile sperm count < 5 million
- Refuse to participate in research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem University
Istanbul, 34746
Pinar Ozcan
Pinar Ozcan
About this study
Official title: Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
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 and IUI cycles 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 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 IUI procedures result in a successful pregnancy of around 10-15%, 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 IUI cycles, 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
- Infertility Unexplained, Infertility, Male
- Being tested
- MicroFluidic Sperm Sorting Chips, Gradient-Density Centrifugation
- Keywords
- microfluid chip, gradient-density, intrauterine insemination
- 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 IUI treatment
Gradient-Density CentrifugationOther
sperm selection of IUI treatment
| Study group | Role | What they receive |
|---|---|---|
| MicroFluidic Sperm Sorting Chips | Experimental | Sperm Sorting microfluidic chips will be used when preparing sperm of male partner and IUI 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 IUI 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 IUI success
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level
Measured: average of 6 months
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 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start15 Nov 2019
- Primary completion15 May 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infertility UnexplainedStudies 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
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144244
- Sponsor's protocol ID
- Microchip IUI study
- Status last verified
- Feb 2020
- First submitted
- 28 Oct 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.
PubMed 31543253Yetkinel S, Kilicdag EB, Aytac PC, Haydardedeoglu B, Simsek E, Cok T. Effects of the microfluidic chip technique in sperm selection for intracytoplasmic sperm injection for unexplained infertility: a prospective, randomized controlled trial. J Assist Reprod Genet. 2019 Mar;36(3):403-409. doi: 10.1007/s10815-018-1375-2. Epub 2018 Dec 12.
PubMed 30542782
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04144244
- Acronym / sponsor ID
- Microchip IUI study
- Conditions
- Infertility Unexplained, Infertility, Male
- Keywords
- microfluid chip, gradient-density, intrauterine insemination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 30 Oct 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 and IUI cycles 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 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 IUI procedures result in a successful pregnancy of around 10-15%, 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 IUI cycles, 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 will be used when preparing sperm of male partner and IUI 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 IUI will be made with separated sperm |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count >5 million)
- Volunteer
Key exclusion criteria (5 listed)
- Inadequate follicle development with medication
- Embryo does not have the appropriate quality for transfer
- Tubal pathology
- Total motile sperm count < 5 million
- 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 IUI treatment | Other | MicroFluidic Sperm Sorting Chips |
| Gradient-Density Centrifugationsperm selection of IUI treatment | Other | gradient-density centrifugation |
Primary outcome
Compare microfluid chip and density-gradient methods in terms of IUI success
Time frame: average of 6 months
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 6 months
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 31543253Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.
- Background: PubMed 30542782Yetkinel S, Kilicdag EB, Aytac PC, Haydardedeoglu B, Simsek E, Cok T. Effects of the microfluidic chip technique in sperm selection for intracytoplasmic sperm injection for unexplained infertility: a prospective, randomized controlled trial. J Assist Reprod Genet. 2019 Mar;36(3):403-409. doi: 10.1007/s10815-018-1375-2. Epub 2018 Dec 12.
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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.
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 Chips and Gradient-Density Centrifugation in people with Infertility Unexplained and Infertility, Male, run by Bezmialem Vakif University at 1 site 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 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: status not confirmed, as of the sponsor's last update on 12 Feb 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar Ozcan, MD, Assoc Prof (+902124531700, drpinarozcan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare microfluid chip and density-gradient methods in terms of IUI success (time frame: average of 6 months). 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 NCT04144244, which also lists 2 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 12 Feb 2020.