Infertility, MaleFERTIMACSNCT04061486
Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip
An observational study of Infertility, Male, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility, Male
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 8 Aug 2019to 9 Jan 2022
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile patients needing an IVF treatment
Who may be able to join
- Oocyte recipient patients
Who cannot join
- Sperm concentration < 5 Mill/ml
- Percentage of motile sperm < 15%
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. The main questions it aims to answer are:
- Does microfluidic sorting improve pregnancy rate compared to MACS?
- Does microfluidic sorting improve fertilization rate compared to MACS?
- Does microfluidic sorting improve implantation rate compared to MACS?
- Does microfluidic sorting improve blastocyst development rate compared to MACS?
Read more
Participants will deposit an eyaculate sample that will be analyzed for DNA fragmentation using a aliquot, then split in two to perform MACS and the microfluidic sorting. Both will be tested for DNA fragmentation (aliquotes) and used for the ICSI treatment with donor oocytes.
Researchers will compare both techniques to see if the selection of the best functional spermatozoa with less DNA fragmentation and clinical outcomes improve.
Read the detailed description
In assisted reproductive technology (ART), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. Any type of damage present in sperm DNA can lead to ART failure. Sperm DNA fragmentation might be the most frequent cause of paternal DNA anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. Such DNA fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal DNA integrity as possible from ejaculated semen.
Because of centrifugation steps associated to swim-up or density-gradient can induce sperm DNA fragmentation via reactive oxygen species (ROS), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. It seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. Hence, this new technology has been proposed to minimize DNA damage. In this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower DNA fragmentation spermatozoa when compared to magnetic activated cell sorting (MACS) in split semen samples, and increases clinical outcomes.
- Conditions
- Infertility, Male
- Keywords
- MACS, DNA fragmentation, Sperm selection
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | One half of the oocyte cohort is microinjected with sperm selected by the Fertile technique, while the other half of the patient's oocyte cohort is microinjected with sperm selected by the MACS technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Total of positive pregnancies / total of patients with embryo transfer
Measured: Mar 2019 - Oct 2021
Secondary outcomes (3)
Fertilization rate
Total of oocyte fertilized / total of oocyte injected
Measured: Mar 2019 - Oct 2021
Implantation rate
Total of implanted embryos / total of transferred embryos
Measured: Mar 2019 - Oct 2021
Blastocyst rate
Total of bastocyst / total of oocyte fertilized
Measured: Mar 2019 - Oct 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start8 Aug 2019
- Primary completion15 May 2021
- Study completion9 Jan 2022
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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Madrid
- Responsible party
- Sponsor
- Investigators
- Cristina González Ravina, PhD, Principal investigator, IVI RMA Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061486
- Sponsor's protocol ID
- 1904-SEV-050-CR
- Acronym
- FERTIMACS
- Status last verified
- Oct 2024
- First submitted
- 16 Aug 2019
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip
- ClinicalTrials.gov ID
- NCT04061486
- Acronym / sponsor ID
- FERTIMACS / 1904-SEV-050-CR
- Conditions
- Infertility, Male
- Keywords
- MACS, DNA fragmentation, Sperm selection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Collaborators
- IVI Madrid
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 9 Jan 2022 (actual)
- First posted
- 19 Aug 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.
The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. The main questions it aims to answer are:
- Does microfluidic sorting improve pregnancy rate compared to MACS?
- Does microfluidic sorting improve fertilization rate compared to MACS?
- Does microfluidic sorting improve implantation rate compared to MACS?
- Does microfluidic sorting improve blastocyst development rate compared to MACS?
Participants will deposit an eyaculate sample that will be analyzed for DNA fragmentation using a aliquot, then split in two to perform MACS and the microfluidic sorting. Both will be tested for DNA fragmentation (aliquotes) and used for the ICSI treatment with donor oocytes.
Researchers will compare both techniques to see if the selection of the best functional spermatozoa with less DNA fragmentation and clinical outcomes improve.
Detailed description
In assisted reproductive technology (ART), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. Any type of damage present in sperm DNA can lead to ART failure. Sperm DNA fragmentation might be the most frequent cause of paternal DNA anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. Such DNA fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal DNA integrity as possible from ejaculated semen.
Because of centrifugation steps associated to swim-up or density-gradient can induce sperm DNA fragmentation via reactive oxygen species (ROS), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. It seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. Hence, this new technology has been proposed to minimize DNA damage. In this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower DNA fragmentation spermatozoa when compared to magnetic activated cell sorting (MACS) in split semen samples, and increases clinical outcomes.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | – | –One half of the oocyte cohort is microinjected with sperm selected by the Fertile technique, while the other half of the patient's oocyte cohort is microinjected with sperm selected by the MACS technique. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile patients needing an IVF treatment
Key inclusion criteria (1 listed)
- Oocyte recipient patients
Key exclusion criteria (2 listed)
- Sperm concentration < 5 Mill/ml
- Percentage of motile sperm < 15%
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
Pregnancy rate
Time frame: Mar 2019 - Oct 2021
Total of positive pregnancies / total of patients with embryo transfer
3 secondary outcomes
Fertilization rate
Time frame: Mar 2019 - Oct 2021
Implantation rate
Time frame: Mar 2019 - Oct 2021
Blastocyst rate
Time frame: Mar 2019 - Oct 2021
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 4 Oct 2024.
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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.
Cristina González Ravina, PhD principal investigator
IVI RMA Seville
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 Vida Recoletas Sevilla 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 1 inclusion and 2 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 4 Oct 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?
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?
Pregnancy rate (time frame: Mar 2019 - Oct 2021). 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 4 Oct 2024.