MACS Technique EfficacyNCT01908569
Application of MACS and Time-lapse Technology in Good-prognosis Patients
A study testing MACS and NO MACS in people with MACS Technique Efficacy, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads, magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin V is a protein with a high affinity for the molecule phosphatidylserine. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- MACS Technique Efficacy
- What is being tested?
- MACS and NO MACS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to Nov 2016
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- <38 years
- >10 follicles with a diameter of ≥10 mm the day before the follicular puncture
Who cannot join
- Patients subject to preimplantation genetic diagnosis treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of MACS (Magnetic-activated Cell Sorting) and Time-lapse Technology (Embryoscope) in Assisted Reproduction Patients With Good Prognosis
The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads, magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine residues on their membrane surface. Using this technique, the apoptotic spermatozoids will join the microbeads and consequently be retained in a column applying a magnetic field.
Recent studies show the benefits of spermatozoid selection using MACS and the improvement in mobility, viability, DNA fragmentation and fertilization potential. It has also been observed an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid survival after thawing. However, it is necessary to perform new clinical studies in order to evaluate the real potential of this technology and its safety.
Read more
The purpose of this study is to evaluate the effect of the MACS technique on the clinical results of good-prognosis patients who are going through IVF/ICSI treatments in order to achieve a pregnancy.
The hypothesis of this study is that the application of the MACS technique in assisted reproduction treatments is associated with a better embryo quality and pregnancy rates.
- Conditions
- MACS Technique Efficacy
- Being tested
- MACS, NO MACS
- Keywords
- MACS, time-lapse, embryo, spermatozoid, sperm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACSOther
The sperm will be subjected to capacitation through a density gradient together with the MACS technique in order to select the non-apoptotic spermatozoids.
NO MACSOther
The sperm capacitation will be performed through a density gradient. The MACS technique will not be applied.
| Study group | Role | What they receive |
|---|---|---|
| NO MACS + Time-lapse technology | Active comparator | The sperm capacitation will be performed through a density gradient. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope). Receives: Other: NO MACS |
| MACS + time-lapse technology | Experimental | The sperm capacitation will be performed through a density gradient. After that, it will be subjected to the MACS technique in order to select the non-apoptotic spermatozoids. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope). Receives: Other: MACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 14 months
Secondary outcomes (3)
Pregnancy rate
Measured: 14 months
Embryo quality
According to ASEBIR criteria
Measured: 14 months
Implantation rate
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MACS Technique EfficacyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Blasco, MSc, Study chair, Vida Recoletas SevillaRocío Quiroga, MSc, Principal investigator, Vida Recoletas SevillaCristina González, PhD, Study chair, Vida Recoletas SevillaCinzia Caligara, MD, Study chair, Vida Recoletas Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908569
- Sponsor's protocol ID
- IVISEV-004ROVIC
- Status last verified
- Sep 2018
- First submitted
- 23 Jul 2013
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of MACS (Magnetic-activated Cell Sorting) and Time-lapse Technology (Embryoscope) in Assisted Reproduction Patients With Good Prognosis
- ClinicalTrials.gov ID
- NCT01908569
- Acronym / sponsor ID
- IVISEV-004ROVIC
- Conditions
- MACS Technique Efficacy
- Keywords
- MACS, time-lapse, embryo, spermatozoid, sperm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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 MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads, magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine residues on their membrane surface. Using this technique, the apoptotic spermatozoids will join the microbeads and consequently be retained in a column applying a magnetic field.
Recent studies show the benefits of spermatozoid selection using MACS and the improvement in mobility, viability, DNA fragmentation and fertilization potential. It has also been observed an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid survival after thawing. However, it is necessary to perform new clinical studies in order to evaluate the real potential of this technology and its safety.
The purpose of this study is to evaluate the effect of the MACS technique on the clinical results of good-prognosis patients who are going through IVF/ICSI treatments in order to achieve a pregnancy.
The hypothesis of this study is that the application of the MACS technique in assisted reproduction treatments is associated with a better embryo quality and pregnancy rates.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO MACS + Time-lapse technology | Active comparator | Other: NO MACSThe sperm capacitation will be performed through a density gradient. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope). |
| MACS + time-lapse technology | Experimental | Other: MACSThe sperm capacitation will be performed through a density gradient. After that, it will be subjected to the MACS technique in order to select the non-apoptotic spermatozoids. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope). |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- <38 years
- >10 follicles with a diameter of ≥10 mm the day before the follicular puncture
Key exclusion criteria (1 listed)
- Patients subject to preimplantation genetic diagnosis treatments
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 |
|---|---|---|
| MACSThe sperm will be subjected to capacitation through a density gradient together with the MACS technique in order to select the non-apoptotic spermatozoids. | Other | MACS + time-lapse technology |
| NO MACSThe sperm capacitation will be performed through a density gradient. The MACS technique will not be applied. | Other | NO MACS + Time-lapse technology |
Primary outcome
Clinical pregnancy rate
Time frame: 14 months
3 secondary outcomes
Pregnancy rate
Time frame: 14 months
Embryo quality
Time frame: 14 months
Implantation rate
Time frame: 14 months
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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.
Victor Blasco, MSc study chair
Vida Recoletas Sevilla
Rocío Quiroga, MSc principal investigator
Vida Recoletas Sevilla
Cristina González, PhD study chair
Vida Recoletas Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MACS and NO MACS in people with MACS Technique Efficacy, 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 2 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: stopped early, as of the sponsor's last update on 5 Sep 2018. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Clinical pregnancy rate (time frame: 14 months). 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 5 Sep 2018.