Intracytoplasmic Sperm InjectionIS-MFluidicsNCT06243926
Sperm Selection by Rheotaxis and Thermotaxis in In-Situ Handmade Microfluidics of Fluidic Walls in the Same ICSI Plate
An observational study of Intracytoplasmic Sperm Injection and Sperm, run by CREA Medicina de la Reproducción SL at 1 site in Spain.
Trial summary
Microfluidics technologies are proving their capability to select suitable sperm for ICSI, especially those that take advantage of the rheotaxic properties of sperm migration. In contrast to other sperm preparation methods such as Wash-Swim-Up and Density- Gradients-Centrifugation (DGC), microfluidics disregards… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracytoplasmic Sperm Injection, Sperm, Microfluidics
- What is being tested?
- Sperm selection for ICSI
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2024to Jun 2024
- Phase
- Observational
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Couples enrolled in our IVF program, who meet the inclusion/exclusion criteria described above
Who may be able to join
- Patients undergoing ICSI
- Female age under 40 years old
- Number of mature oocytes (MII) upon oocyte retrieval ≥ 6
- Male age under 50 years old
- Total number of progressive sperm ≥ 1 million
Who cannot join
- Patients with surgically retrieved sperm for ICSI
- Cases using cryopreserved oocytes
- Cases using cryopreserved sperm
Trial locations and contacts
1 site in 1 country.
Miguel Ruiz-Jorro, MD, MSc, PhD contact
Spain1 site, 1 recruiting
- Recruiting
CREA Medicina de la Reproducción
Valencia, 46003
Minerva Ferrer-Buitrago, PhD, +34622342562, minerva.ferrer@creavalencia.com
Miguel Ruiz-Jorro, PhD
About this study
Official title: Clinical Outcomes Following the Sperm Selection by Rheotaxis and Thermotaxis in In-Situ Hand-made Microfluidics of Fluidic Walls in the Same ICSI Plate: a Randomized Controlled Trial
Microfluidics technologies are proving their capability to select suitable sperm for ICSI, especially those that take advantage of the rheotaxic properties of sperm migration. In contrast to other sperm preparation methods such as Wash-Swim-Up and Density- Gradients-Centrifugation (DGC), microfluidics disregards washing and centrifugation steps along the procedure. However, microfluidics devices are costly and likely to fail to select motile sperm in dispermic samples. The investigators have recently described a novel approach for sperm selection by In-Situ handmade rheotaxis microfluidics of fluidic walls in the same ICSI plate. This methodology integrates a swim-over based on horizontal migration with a positive rheotaxis zone. The present study aims to deliver an unbiased comparison between two sperm selection techniques: DGC and In-Situ handmade rheotaxis microfluidics of fluidic walls (isM).
Read the detailed description
Microfluidics technologies stand as the latest sperm selection methodology for ICSI. Increasingly, publications show novel and ingenious microfluidics strategies to integrate sperm biomimicry during in vitro sperm selection while simplifying the IVF workflow. Microfluidics are time-efficient methods which reduce the risks associated with handling, gamete mix-up and ROS production. However, microfluidics devices are costly and likely to fail to select motile sperm in dispermic samples. Aiming to outline the application of microfluidics in ART, the investigators conceived a lab-on-a-chip approach for sperm selection by In-Situ rheotaxis handmade microfluidics of fluidic walls. This microfluidics system allows selecting sperm for ICSI in the same ICSI-dish. Thus, from a microvolume of the raw semen sample, only using microfluidics, disregarding centrifugation, washing, plasticware, other cells, products or materials, and using the same culture medium needed to prepare the rest of the ICSI plate.
A previous proof-of-concept study showed that this methodology efficiently selected suitable sperm for ICSI. The investigators also demonstrated that the microfluidic protocol effectively separates at least 20 progressive spermatozoa in less than 15 minutes in a clean microdroplet, free of any remaining seminal plasma. A subsequent non-inferiority study showed that the microfluidic method performs as well as density gradient centrifugation to achieve ICSI outcomes such as fertilization and day-5 blastocyst formation rate, proving that In-Situ handmade rheotaxis microfluidics of fluidic walls are also effective in supporting pre-implantation embryonic development in vitro.
- Conditions
- Intracytoplasmic Sperm Injection, Sperm, Microfluidics
- Being tested
- Sperm selection for ICSI
- Keywords
- ICSI, Sperm Selection, Microfluidics, Assisted Reproduction Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm selection for ICSIOther
Also called Sperm capacitation, Sperm sorting, Sperm separation, Sperm recovery
Sperm selection for ICSI is a critical step to ensure the use of viable and healthy sperm for fertilization in vitro. The goal is to choose a sperm that has the best chance of resulting in a successful pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Density gradient centrifugation (DGC) | DGC is a protocol to select sperm based on their density and isopycnic points. It is a conventional protocol commonly used in IVF laboratories. Receives: Other: Sperm selection for ICSI | |
| In-Situ rheotaxis handmade microfluidics (isM) | The isM is a novel protocol to select sperm for ICSI based on microfluidics and sperm guidance responses to rheotaxis and thermotaxis. The isM protocol proved its efficacy and effectivity for ICSI in previous proof of concept and non-inferiority studies, respectively. Receives: Other: Sperm selection for ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization Rate (FR)
The proportion of two-pronuclei zygote divided by the total number of matured and microinjected oocytes (2pn/MII, %)
Measured: 16 to 20 hours post-ICSI (day 1)
Day 5 usable blastocyst rate (D5UBR)
The proportion of embryos classified as blastocysts at day 5 of development, which has been transferred and/or cryopreserved.
Measured: 108 to 113 hours post-ICSI (day 5)
Blastocyst quality grade
Blastocysts are categorized following the scale described by the Spanish Association of Reproduction Biology Studies (ASEBIR). The ASEBIR classification categorizes blastocysts based on their morphology into four groups: from A (highest, better outcome) to D (lowest, worse outcome).
Measured: 108 to 113 hours post-ICSI (day 5)
Secondary outcomes (10)
Morphokinetics profile (MK PNa)
The proportion of embryos showing the appearance of pronuclei (PNa) out of the expected time frame.
Measured: from 16 to 20 hours post-ICSI (day 1)
Morphokinetics profile (MK PNf)
The proportion of embryos showing the fading of pronuclei (PNf) out of the expected time frame.
Measured: from 24 to 25 hours post-ICSI (day 1)
Morphokinetics profile (MK t2)
The proportion of embryos showing 2 cells (t2) out of the expected time frame.
Measured: from 24 to 28 hours post-ICSI (day 1)
Morphokinetics profile (MK t4)
The proportion of embryos showing 4 cells (t4) out of the expected time frame.
Measured: from 37 to 41hours post-ICSI (day 2)
Morphokinetics profile (MK t8)
The proportion of embryos showing 8 cells (t8) out of the expected time frame.
Measured: from 51 to 69 hours post-ICSI (day 3)
Morphokinetics profile (MK tM)
The proportion of embryos with full cell compaction (morula; tM) out of the expected time frame.
Measured: from 81 to 96 hours post-ICSI (day 4)
Morphokinetics profile (MK tSB)
The proportion of embryos starting to blastulate (tSB) out of the expected time frame.
Measured: from 99 to 101 hours post-ICSI (day 5)
Morphokinetics profile (MK tB)
The proportion of embryos starting to blastulate (tB) out of the expected time frame.
Measured: from 108 to 113 hours post-ICSI (day 5)
Implantation Rate (IR)
The proportion of embryos that were transferred that develop to a gestational sac
Measured: 5 to 6 gestational weeks
Ongoing clinical pregnancy Rate (OCP)
The proportion of embryos that were transferred that develop at least to the stage of fetal heart activity
Measured: 6 to 8 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start8 Jan 2024
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracytoplasmic Sperm InjectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CREA Medicina de la Reproducción SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Ruiz-Jorro MD, MSc, PhD, Principal investigator, CREA. Medicina de la Reproducción S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243926
- Sponsor's protocol ID
- e.23.I
- Acronym
- IS-MFluidics
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 6 Feb 2024
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Following the Sperm Selection by Rheotaxis and Thermotaxis in In-Situ Hand-made Microfluidics of Fluidic Walls in the Same ICSI Plate: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06243926
- Acronym / sponsor ID
- IS-MFluidics / e.23.I
- Conditions
- Intracytoplasmic Sperm Injection, Sperm, Microfluidics
- Keywords
- ICSI, Sperm Selection, Microfluidics, Assisted Reproduction Techniques
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CREA Medicina de la Reproducción SLUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 6 Feb 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.
Microfluidics technologies are proving their capability to select suitable sperm for ICSI, especially those that take advantage of the rheotaxic properties of sperm migration. In contrast to other sperm preparation methods such as Wash-Swim-Up and Density- Gradients-Centrifugation (DGC), microfluidics disregards washing and centrifugation steps along the procedure. However, microfluidics devices are costly and likely to fail to select motile sperm in dispermic samples. The investigators have recently described a novel approach for sperm selection by In-Situ handmade rheotaxis microfluidics of fluidic walls in the same ICSI plate. This methodology integrates a swim-over based on horizontal migration with a positive rheotaxis zone. The present study aims to deliver an unbiased comparison between two sperm selection techniques: DGC and In-Situ handmade rheotaxis microfluidics of fluidic walls (isM).
Detailed description
Microfluidics technologies stand as the latest sperm selection methodology for ICSI. Increasingly, publications show novel and ingenious microfluidics strategies to integrate sperm biomimicry during in vitro sperm selection while simplifying the IVF workflow. Microfluidics are time-efficient methods which reduce the risks associated with handling, gamete mix-up and ROS production. However, microfluidics devices are costly and likely to fail to select motile sperm in dispermic samples. Aiming to outline the application of microfluidics in ART, the investigators conceived a lab-on-a-chip approach for sperm selection by In-Situ rheotaxis handmade microfluidics of fluidic walls. This microfluidics system allows selecting sperm for ICSI in the same ICSI-dish. Thus, from a microvolume of the raw semen sample, only using microfluidics, disregarding centrifugation, washing, plasticware, other cells, products or materials, and using the same culture medium needed to prepare the rest of the ICSI plate.
A previous proof-of-concept study showed that this methodology efficiently selected suitable sperm for ICSI. The investigators also demonstrated that the microfluidic protocol effectively separates at least 20 progressive spermatozoa in less than 15 minutes in a clean microdroplet, free of any remaining seminal plasma. A subsequent non-inferiority study showed that the microfluidic method performs as well as density gradient centrifugation to achieve ICSI outcomes such as fertilization and day-5 blastocyst formation rate, proving that In-Situ handmade rheotaxis microfluidics of fluidic walls are also effective in supporting pre-implantation embryonic development in vitro.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Density gradient centrifugation (DGC) | – | Other: Sperm selection for ICSIDGC is a protocol to select sperm based on their density and isopycnic points. It is a conventional protocol commonly used in IVF laboratories. |
| In-Situ rheotaxis handmade microfluidics (isM) | – | Other: Sperm selection for ICSIThe isM is a novel protocol to select sperm for ICSI based on microfluidics and sperm guidance responses to rheotaxis and thermotaxis. The isM protocol proved its efficacy and effectivity for ICSI in previous proof of concept and non-inferiority studies, respectively. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Couples enrolled in our IVF program, who meet the inclusion/exclusion criteria described above
Key inclusion criteria (5 listed)
- Patients undergoing ICSI
- Female age under 40 years old
- Number of mature oocytes (MII) upon oocyte retrieval ≥ 6
- Male age under 50 years old
- Total number of progressive sperm ≥ 1 million
Key exclusion criteria (3 listed)
- Patients with surgically retrieved sperm for ICSI
- Cases using cryopreserved oocytes
- Cases using cryopreserved sperm
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 selection for ICSIAlso: Sperm capacitation, Sperm sorting, Sperm separation, Sperm recoverySperm selection for ICSI is a critical step to ensure the use of viable and healthy sperm for fertilization in vitro. The goal is to choose a sperm that has the best chance of resulting in a successful pregnancy. | Other | Density gradient centrifugation (DGC), In-Situ rheotaxis handmade microfluidics (isM) |
Primary outcome
Fertilization Rate (FR)
Time frame: 16 to 20 hours post-ICSI (day 1)
The proportion of two-pronuclei zygote divided by the total number of matured and microinjected oocytes (2pn/MII, %)
Day 5 usable blastocyst rate (D5UBR)
Time frame: 108 to 113 hours post-ICSI (day 5)
The proportion of embryos classified as blastocysts at day 5 of development, which has been transferred and/or cryopreserved.
Blastocyst quality grade
Time frame: 108 to 113 hours post-ICSI (day 5)
Blastocysts are categorized following the scale described by the Spanish Association of Reproduction Biology Studies (ASEBIR). The ASEBIR classification categorizes blastocysts based on their morphology into four groups: from A (highest, better outcome) to D (lowest, worse outcome).
10 secondary outcomes
Morphokinetics profile (MK PNa)
Time frame: from 16 to 20 hours post-ICSI (day 1)
Morphokinetics profile (MK PNf)
Time frame: from 24 to 25 hours post-ICSI (day 1)
Morphokinetics profile (MK t2)
Time frame: from 24 to 28 hours post-ICSI (day 1)
Morphokinetics profile (MK t4)
Time frame: from 37 to 41hours post-ICSI (day 2)
Morphokinetics profile (MK t8)
Time frame: from 51 to 69 hours post-ICSI (day 3)
Morphokinetics profile (MK tM)
Time frame: from 81 to 96 hours post-ICSI (day 4)
Morphokinetics profile (MK tSB)
Time frame: from 99 to 101 hours post-ICSI (day 5)
Morphokinetics profile (MK tB)
Time frame: from 108 to 113 hours post-ICSI (day 5)
Implantation Rate (IR)
Time frame: 5 to 6 gestational weeks
Ongoing clinical pregnancy Rate (OCP)
Time frame: 6 to 8 gestational weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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. This study is not recruiting at the moment.
Miguel Ruiz-Jorro, MD, MSc, PhD contact
Miguel Ruiz-Jorro MD, MSc, PhD principal investigator
CREA. Medicina de la Reproducción S.L.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracytoplasmic Sperm Injection and Sperm, run by CREA Medicina de la Reproducción SL at 1 site 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 3 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 6 Feb 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minerva Ferrer-Buitrago, BSc, PGDip, PhD (+34622342562, minerva.ferrer@creavalencia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization Rate (FR) (time frame: 16 to 20 hours post-ICSI (day 1)). The study lists 3 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 6 Feb 2024.