Reduced Sperm MotilityNCT04962074
Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods
A study testing Microfluidic sperm sorting chip and Density gradient in people with Reduced Sperm Motility and IVF, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To compare the effects of the density gradient centrifugation and microfluidic chip sperm preparation methods on embryo development in a study population with astheno-teratozoospermia. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Reduced Sperm Motility, IVF, ICSI
- What is being tested?
- Microfluidic sperm sorting chip and Density gradient
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2020to 20 Sep 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infertile men with astheno-teratozoospermia
- Women were aged from 18 to 39
- Women had at least two mature oocytes.
Who cannot join
- MI oocytes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods
Purpose: To compare the effects of the density gradient centrifugation and microfluidic chip sperm preparation methods on embryo development in a study population with astheno-teratozoospermia.
Materials and Methods: In this prospective study, the semen samples of the patients with astheno-teratozoospermia were divided into two groups for preparation with either the microfluidic or density gradient methods. Selected spermatozoa were used to fertilize the mature sibling oocytes. Semen parameters and embryo development on days 3 and 5 were assessed.
- Conditions
- Reduced Sperm Motility, IVF, ICSI, Astheno Teratozoospermia
- Being tested
- Microfluidic sperm sorting chip, Density gradient
- Keywords
- Sperm, IVF, ICSI, Abnormal morphology of sperm, Astheno Teratozoospermia, Microfluidic chip
- Medical subject headings
- Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfluidic sperm sorting chipDevice
Fertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips
Density gradientDevice
Density gradient centrifugation
| Study group | Role | What they receive |
|---|---|---|
| Density gradient method | Experimental | Sperm prepared by density gradient method Receives: Device: Density gradient |
| Microfluidic chip | Experimental | Sperm prepared by microfluidic chip method Receives: Device: Microfluidic sperm sorting chip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen parameters after sperm preparation with either method: semen volume
semen volume (ml)
Measured: up to 7 months
Semen parameters after sperm preparation with either method: sperm concentration
sperm concentration (106/ml)
Measured: up to 7 months
Semen parameters after sperm preparation with either method: total motility
total motility (%)
Measured: up to 7 months
Semen parameters after sperm preparation with either method: progressive motility
progressive motility (%)
Measured: up to 7 months
Embryo development after sperm preparation with either method
Embryo development and blastocyst formation were evaluated on days 1, 3 and 5 based on the criteria reported by Veeck and Zaninovic, 2003
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start5 Jan 2020
- Primary completion20 Sep 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduced Sperm MotilityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962074
- Sponsor's protocol ID
- 2019
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods
- ClinicalTrials.gov ID
- NCT04962074
- Acronym / sponsor ID
- 2019
- Conditions
- Reduced Sperm Motility, IVF, ICSI, Astheno Teratozoospermia
- Keywords
- Sperm, IVF, ICSI, Abnormal morphology of sperm, Astheno Teratozoospermia, Microfluidic chip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 14 Jul 2021 (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.
Purpose: To compare the effects of the density gradient centrifugation and microfluidic chip sperm preparation methods on embryo development in a study population with astheno-teratozoospermia.
Materials and Methods: In this prospective study, the semen samples of the patients with astheno-teratozoospermia were divided into two groups for preparation with either the microfluidic or density gradient methods. Selected spermatozoa were used to fertilize the mature sibling oocytes. Semen parameters and embryo development on days 3 and 5 were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Density gradient method | Experimental | Device: Density gradientSperm prepared by density gradient method |
| Microfluidic chip | Experimental | Device: Microfluidic sperm sorting chipSperm prepared by microfluidic chip method |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Infertile men with astheno-teratozoospermia
- Women were aged from 18 to 39
- Women had at least two mature oocytes.
Key exclusion criteria (1 listed)
- MI oocytes
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 chipFertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips | Device | Microfluidic chip |
| Density gradientDensity gradient centrifugation | Device | Density gradient method |
Primary outcome
Semen parameters after sperm preparation with either method: semen volume
Time frame: up to 7 months
semen volume (ml)
Semen parameters after sperm preparation with either method: sperm concentration
Time frame: up to 7 months
sperm concentration (106/ml)
Semen parameters after sperm preparation with either method: total motility
Time frame: up to 7 months
total motility (%)
Semen parameters after sperm preparation with either method: progressive motility
Time frame: up to 7 months
progressive motility (%)
Embryo development after sperm preparation with either method
Time frame: up to 7 months
Embryo development and blastocyst formation were evaluated on days 1, 3 and 5 based on the criteria reported by Veeck and Zaninovic, 2003
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 14 Jul 2021.
- Individual participant dataSharing planned: No
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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.
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 chip and Density gradient in people with Reduced Sperm Motility and IVF, run by Maltepe 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 3 inclusion and 1 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 14 Jul 2021. 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?
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?
Semen parameters after sperm preparation with either method: semen volume (time frame: up to 7 months). The study lists 5 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 14 Jul 2021.