Infertility, MaleZYMOT2NCT06384794
Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.
A study testing Sperm capacitation through the ZyMōt®Sperm Separation Device® and Swim-up in people with Infertility, Male and Sperm Count, Low, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.
Trial summary
It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility, Male, Sperm Count, Low
- What is being tested?
- Sperm capacitation through the ZyMōt®Sperm Separation Device® and Swim-up
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- 29 Jun 2023to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for Aneuploidy).
- Males over 18 years of age whose semen sample meets the basic conditions predetermined by the ZyMōt Multi 850µL chip.
- Fresh semen samples.
- Embryos are to be deposited in a time-lapse incubator.
- Women over 37 years of age who have obtained in follicular puncture a number of MII oocytes greater than or equal to 4.
Who cannot join
- Males with severe asthenozoospermia (<10% progressively motile spermatozoa), globozoospermia (spermatozoa with morphological alterations and lack of acrosome) and/or azoospermia (absence of spermatozoa in the ejaculate).
- Seminal samples obtained by testicular biopsy.
- Samples incubated with calcium ionophore.
- Males and females with previously known abnormal karyotype.
- Oocytes coming from the oocyte donation program.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Ivirma Madrid
Madrid, 28023
MONICA TORIBIO, +34 651 79 10 00, IVESMADRID@IVIRMA.COM
Alberto Pacheco, PhD
- Recruiting
Ivirma Valencia
Valencia, 46015
Maria Jose Delossantos, PhD, 34963050900, mariajose.delossantos@ivi.es
Laura Caracena, Mrs, 34963050900 ext. 11054, laura.caracena@ivirma.com
About this study
It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.
- Conditions
- Infertility, Male, Sperm Count, Low
- Being tested
- Sperm capacitation through the ZyMōt®Sperm Separation Device®, Swim-up
- Keywords
- ZyMöt, Sperm fragmentation, Embryo development, Euploidy
- Medical subject headings
- Infertility, Male, Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm capacitation through the ZyMōt®Sperm Separation Device®Device
This chip based on microfluidic properties will help us to separate and recover the semen sample with improved sperm quality. It is composed of two microwells, one initial and one final, and a porous membrane through which the sample will be filtered and the capacitated spermatozoa with better motility will be selected. Syringe 850µL of the initial seminal sample into the first well and 750µL of seminal wash medium into the second well. The device is incubated at 37°C for up to 30 minutes. During this incubation, the sample will travel by microfluidic properties from the first well through the porous membrane to the second well. This membrane will filter those spermatozoa with a higher motility. Thus, at the end of the established incubation time, the medium with the selected spermatozoa from the second well (final well) will be collected with a syringe. After this, the sample will be processed and ready for the following procedures.
Swim-upProcedure or surgery
Also called Sperm capacitation throught swim-up technique
The swim-up is a sperm capacitation technique in which the motile spermatozoa of the seminal sample, after centrifugation and incubation, move to the upper part of the medium. In this way, spermatozoa with good progressive motility will remain in the supernatant.
| Study group | Role | What they receive |
|---|---|---|
| SWIM-UP | Active comparator | Half of the sample from the same patient will be processed by the capacitation technique routinely used in the clinic, swim-up: this is a sperm capacitation technique in which the motile spermatozoa in the seminal sample, after centrifugation and incubation, move to the top of the medium. In this way, spermatozoa with good progressive motility will remain in the supernatant. Receives: Procedure: Swim-up |
| ZYMOT | Experimental | Half of the semen sample will be processed through the ZyMōt® Sperm Separation Device sperm separation chip: This chip based on microfluidic properties will help us to separate and recover the semen sample with an improvement in the quality of the spermatozoa, the capacitated spermatozoa with better motility will be selected. Receives: Device: Sperm capacitation through the ZyMōt®Sperm Separation Device® |
What is being measured
The primary outcome is the main question the study is designed to answer.
EUPLOIDY RATE
Evaluate euploidy rate and compare it between both groups
Measured: 1 YEAR
Secondary outcomes (6)
MOBILITY RATE
Evaluate and compare mobility between both groups
Measured: 1 year
VITALITY RATE
Evaluate and compare vitality between both groups
Measured: 1 year
DNA FRAGMENTATION RATE
Evaluate and compare DNA fragmentation between both groups
Measured: 1 YEAR
SPERM RETRIEVAL RATE
Evaluate and compare sperm retrieval rate between both groups
Measured: 1 years
FERTILIZATION RATE
Evaluate the effect of ZyMōt on the fertilization rate
Measured: 1 year
USEFUL BLASTOCYS RATE
To evaluate number of useful blastocyst per number of MII oocyte injected and fertilized.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start29 Jun 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, prospective, experimental study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Madrid
- Responsible party
- Sponsor
- Investigators
- MARIA JOSE DE LOS SANTOS, PhD, Principal investigator, IVIRMA Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384794
- Sponsor's protocol ID
- 2211-VLC-157-MD
- Acronym
- ZYMOT2
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.
- ClinicalTrials.gov ID
- NCT06384794
- Acronym / sponsor ID
- ZYMOT2 / 2211-VLC-157-MD
- Conditions
- Infertility, Male, Sperm Count, Low
- Keywords
- ZyMöt, Sperm fragmentation, Embryo development, Euploidy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- IVI Madrid
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2024 (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.
It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric, prospective, experimental study.
| Arm | Type | Receives |
|---|---|---|
| SWIM-UP | Active comparator | Procedure: Swim-upHalf of the sample from the same patient will be processed by the capacitation technique routinely used in the clinic, swim-up: this is a sperm capacitation technique in which the motile spermatozoa in the seminal sample, after centrifugation and incubation, move to the top of the medium. In this way, spermatozoa with good progressive motility will remain in the supernatant. |
| ZYMOT | Experimental | Device: Sperm capacitation through the ZyMōt®Sperm Separation Device®Half of the semen sample will be processed through the ZyMōt® Sperm Separation Device sperm separation chip: This chip based on microfluidic properties will help us to separate and recover the semen sample with an improvement in the quality of the spermatozoa, the capacitated spermatozoa with better motility will be selected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for Aneuploidy).
- Males over 18 years of age whose semen sample meets the basic conditions predetermined by the ZyMōt Multi 850µL chip.
- Fresh semen samples.
- Embryos are to be deposited in a time-lapse incubator.
- Women over 37 years of age who have obtained in follicular puncture a number of MII oocytes greater than or equal to 4.
Key exclusion criteria (5 listed)
- Males with severe asthenozoospermia (<10% progressively motile spermatozoa), globozoospermia (spermatozoa with morphological alterations and lack of acrosome) and/or azoospermia (absence of spermatozoa in the ejaculate).
- Seminal samples obtained by testicular biopsy.
- Samples incubated with calcium ionophore.
- Males and females with previously known abnormal karyotype.
- Oocytes coming from the oocyte donation program.
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 |
|---|---|---|
| Sperm capacitation through the ZyMōt®Sperm Separation Device®This chip based on microfluidic properties will help us to separate and recover the semen sample with improved sperm quality. It is composed of two microwells, one initial and one final, and a porous membrane through which the sample will be filtered and the capacitated spermatozoa with better motility will be selected. Syringe 850µL of the initial seminal sample into the first well and 750µL of seminal wash medium into the second well. The device is incubated at 37°C for up to 30 minutes. During this incubation, the sample will travel by microfluidic properties from the first well through the porous membrane to the second well. This membrane will filter those spermatozoa with a higher motility. Thus, at the end of the established incubation time, the medium with the selected spermatozoa from the second well (final well) will be collected with a syringe. After this, the sample will be processed and ready for the following procedures. | Device | ZYMOT |
| Swim-upAlso: Sperm capacitation throught swim-up techniqueThe swim-up is a sperm capacitation technique in which the motile spermatozoa of the seminal sample, after centrifugation and incubation, move to the upper part of the medium. In this way, spermatozoa with good progressive motility will remain in the supernatant. | Procedure or surgery | SWIM-UP |
Primary outcome
EUPLOIDY RATE
Time frame: 1 YEAR
Evaluate euploidy rate and compare it between both groups
6 secondary outcomes
MOBILITY RATE
Time frame: 1 year
VITALITY RATE
Time frame: 1 year
DNA FRAGMENTATION RATE
Time frame: 1 YEAR
SPERM RETRIEVAL RATE
Time frame: 1 years
FERTILIZATION RATE
Time frame: 1 year
USEFUL BLASTOCYS RATE
Time frame: 1 year
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 29 Apr 2024.
- 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.
MARIA JOSE DE LOS SANTOS, PhD principal investigator
IVIRMA Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm capacitation through the ZyMōt®Sperm Separation Device® and Swim-up in people with Infertility, Male and Sperm Count, Low, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.
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 29 Apr 2024. 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 Spain. 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 MARIA LUISA PARDIÑAS, Pre-Doc (+34 963.05.90.00, marialuisa.pardiñas@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EUPLOIDY RATE (time frame: 1 YEAR). 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 29 Apr 2024.