Infertility, MaleMSSNCT04997070
Sperm Selection Using Microfluidic Technology
An observational study of Infertility, Male, run by CRG UZ Brussel at 1 site in Belgium.
Trial summary
This clinical study has been organised to investigate whether microfluidic technology may be considered as a new procedure for routine sperm preparation during assisted reproduction. This is a technique that is already used in other centres. Read more about this study
- Who is it for?
- Ages 18 to 43 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male
- How many people
- 1,038 participants
- Where
- 1 siteBelgium
- Study dates
- 16 May 2022to 1 Mar 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 43 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Couples undergoing ICSI procedure in CRG UZ Brussel will be included in the trial if they fulfil the inclusion criteria listed.
Who may be able to join
- ICSI cycles planned for embryo transfer or 'freeze all' procedure
- Day 5 or day 3/5 embryo culture
- Fresh semen samples with ≥ 1x106 sperm/ml (raw) and Motility of 30% Grade A+B
- At least 6 follicles of ≥14 mm at the day of hCG administration
- Minimum 6 mature oocytes after oocyte pick up
Who cannot join
- Cycles with frozen semen sample
- Cycles with testicular sample
- In vitro fertilization (IVF) cycles
- In vitro maturation cycles
- Managed Natural Cycles (MNC)
- Egg bank- Acceptors
- PGT cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Embryo Quality After Sperm Selection Using Microfluidic Technology: Study on Sibling Oocytes
This clinical study has been organised to investigate whether microfluidic technology may be considered as a new procedure for routine sperm preparation during assisted reproduction. This is a technique that is already used in other centres.
The Microfluidic Sperm Sorting (MSS) technology reduces the time of sample preparation while selects a sperm population with better motility and less DNA fragmentation as compared to routine procedures. This med-ical device is already CE marked.
Having the intention to implement this technology in our department, we conduct this study to investigate whether the use of MSS has at least the same impact, if not better, on fertilization and embryo quality as compared to standard sperm selection procedures.
Read the detailed description
To perform ICSI, the best spermatozoa are selected based on their motility. This is done using a standard procedure which is time-consuming and involves centrifugation steps known to induce sperm DNA damage. Just before ICSI, the selection of the sperm cell that will be injected into the egg is based on morphological assessment (at 400x inverted phase contrast microscopy). However, the spermatozoa with DNA damage cannot be identified using microscopic procedures and therefore cannot be excluded for ICSI. It was reported that the sperm cells with DNA damage have a negative impact on embryo development and are correlated with increased miscarriage rate.
A more "close to nature" approach is now available due to the microfluidic sperm sorting (MSS) technology that is using FERTILE series devices (FERTILE and FERTILE PLUS, Koek EU, GmbH). The method is based on the principle of natural sperm selection in a passage through micro-barriers imitating natural environment of female reproductive system (fallopian tubes).
This chemical-free technology does not require any pretreatment of the semen sample, while the sorted sperm shows high motility and low levels of DNA damage. At the day of pick up, the husband provides the semen sample. The sample obtained will be divided in 2 fractions: one fraction will be subject to Microfluidic technology (fraction 1) and the other fraction will represent the control (conventionally prepared sperm; fraction 2).
This device was tested in our laboratory on diagnostic semen samples and proved to select the best sperm population when compared to the standard method.
Due to the encouraging results, we intend to apply microfluidic as the routine procedure for sperm preparation in our department. This procedure will increase the chance of using sperm cells without DNA damage during ICSI and therefore we expect better embryological outcome.
This clinical study has been organised to determine if the embryo quality on day 5 will be similar or better when using microfluidic technology compared to standard procedure.
At the moment of ICSI, half of the eggs of good quality (mature) will be inseminated with sperm from fraction 1 and the other half with sperm from fraction 2. The decision of which fraction will be used to inject the first half of the oocytes is random and is based on a list generated by the computer.
The retrieved oocytes will follow the normal lab procedure after injection: the embryos available on day 3 or day 5/6 that meet our criteria for transfer or cryopreservation will be used for transfer or cryopreservation, no matter from which fraction the sperm was used.
- Conditions
- Infertility, Male
- Medical subject headings
- Infertility, Male
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo quality
Compare the embryo quality (Gardner score - Scale blastocyst 1-6 where 6 is best; Inner cell mass A-D where A is best; Throphectoderm A-C where A is best) on day 5 between the two groups.
Measured: 2 years
Secondary outcomes (2)
Fertilization rate
Compare the fertilization rate (number of fertilized oocytes per number of injected oocytes) between the two groups.
Measured: 2 years
Embryo morphokinetic parameters
Compare the embryo morphokinetic parameters from day 0 until day 6 recorded via embryoscope Plus (Vitrolife sa) between the two group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start16 May 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- CRG UZ Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Wouters, CRG UZ Brussel
- Investigators
- Koen Wouters, Msc, Principal investigator, Brussels IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997070
- Sponsor's protocol ID
- 2021-185
- Acronym
- MSS
- Status last verified
- Mar 2024
- First submitted
- 4 Aug 2021
- Last updated
- 6 Mar 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Embryo Quality After Sperm Selection Using Microfluidic Technology: Study on Sibling Oocytes
- ClinicalTrials.gov ID
- NCT04997070
- Acronym / sponsor ID
- MSS / 2021-185
- Conditions
- Infertility, Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- CRG UZ BrusselUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 9 Aug 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.
This clinical study has been organised to investigate whether microfluidic technology may be considered as a new procedure for routine sperm preparation during assisted reproduction. This is a technique that is already used in other centres.
The Microfluidic Sperm Sorting (MSS) technology reduces the time of sample preparation while selects a sperm population with better motility and less DNA fragmentation as compared to routine procedures. This med-ical device is already CE marked.
Having the intention to implement this technology in our department, we conduct this study to investigate whether the use of MSS has at least the same impact, if not better, on fertilization and embryo quality as compared to standard sperm selection procedures.
Detailed description
To perform ICSI, the best spermatozoa are selected based on their motility. This is done using a standard procedure which is time-consuming and involves centrifugation steps known to induce sperm DNA damage. Just before ICSI, the selection of the sperm cell that will be injected into the egg is based on morphological assessment (at 400x inverted phase contrast microscopy). However, the spermatozoa with DNA damage cannot be identified using microscopic procedures and therefore cannot be excluded for ICSI. It was reported that the sperm cells with DNA damage have a negative impact on embryo development and are correlated with increased miscarriage rate.
A more "close to nature" approach is now available due to the microfluidic sperm sorting (MSS) technology that is using FERTILE series devices (FERTILE and FERTILE PLUS, Koek EU, GmbH). The method is based on the principle of natural sperm selection in a passage through micro-barriers imitating natural environment of female reproductive system (fallopian tubes).
This chemical-free technology does not require any pretreatment of the semen sample, while the sorted sperm shows high motility and low levels of DNA damage. At the day of pick up, the husband provides the semen sample. The sample obtained will be divided in 2 fractions: one fraction will be subject to Microfluidic technology (fraction 1) and the other fraction will represent the control (conventionally prepared sperm; fraction 2).
This device was tested in our laboratory on diagnostic semen samples and proved to select the best sperm population when compared to the standard method.
Due to the encouraging results, we intend to apply microfluidic as the routine procedure for sperm preparation in our department. This procedure will increase the chance of using sperm cells without DNA damage during ICSI and therefore we expect better embryological outcome.
This clinical study has been organised to determine if the embryo quality on day 5 will be similar or better when using microfluidic technology compared to standard procedure.
At the moment of ICSI, half of the eggs of good quality (mature) will be inseminated with sperm from fraction 1 and the other half with sperm from fraction 2. The decision of which fraction will be used to inject the first half of the oocytes is random and is based on a list generated by the computer.
The retrieved oocytes will follow the normal lab procedure after injection: the embryos available on day 3 or day 5/6 that meet our criteria for transfer or cryopreservation will be used for transfer or cryopreservation, no matter from which fraction the sperm was used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Couples undergoing ICSI procedure in CRG UZ Brussel will be included in the trial if they fulfil the inclusion criteria listed.
Key inclusion criteria (5 listed)
- ICSI cycles planned for embryo transfer or 'freeze all' procedure
- Day 5 or day 3/5 embryo culture
- Fresh semen samples with ≥ 1x106 sperm/ml (raw) and Motility of 30% Grade A+B
- At least 6 follicles of ≥14 mm at the day of hCG administration
- Minimum 6 mature oocytes after oocyte pick up
Key exclusion criteria (7 listed)
- Cycles with frozen semen sample
- Cycles with testicular sample
- In vitro fertilization (IVF) cycles
- In vitro maturation cycles
- Managed Natural Cycles (MNC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Embryo quality
Time frame: 2 years
Compare the embryo quality (Gardner score - Scale blastocyst 1-6 where 6 is best; Inner cell mass A-D where A is best; Throphectoderm A-C where A is best) on day 5 between the two groups.
2 secondary outcomes
Fertilization rate
Time frame: 2 years
Embryo morphokinetic parameters
Time frame: 2 years
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 6 Mar 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.
Koen Wouters, Msc principal investigator
Brussels IVF
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 Infertility, Male, run by CRG UZ Brussel at 1 site in Belgium.
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 7 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 6 Mar 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 Belgium. 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?
Embryo quality (time frame: 2 years). 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 Mar 2024.