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Application of MACS and Time-lapse Technology in Good-prognosis Patients

Application of MACS (Magnetic-activated Cell Sorting) and Time-lapse Technology (Embryoscope) in Assisted Reproduction Patients With Good Prognosis

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01908569
Enrollment
66
Registered
2013-07-25
Start date
2013-07-31
Completion date
2016-11-30
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MACS Technique Efficacy

Keywords

MACS, time-lapse, embryo, spermatozoid, sperm

Brief 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. 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.

Interventions

OTHERMACS

The sperm will be subjected to capacitation through a density gradient together with the MACS technique in order to select the non-apoptotic spermatozoids.

OTHERNO MACS

The sperm capacitation will be performed through a density gradient. The MACS technique will not be applied.

Sponsors

Vida Recoletas Sevilla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No

Inclusion criteria

* \<38 years * \>10 follicles with a diameter of ≥10 mm the day before the follicular puncture

Exclusion criteria

* Patients subject to preimplantation genetic diagnosis treatments

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate14 months

Secondary

MeasureTime frameDescription
Pregnancy rate14 months
Embryo quality14 monthsAccording to ASEBIR criteria
Implantation rate14 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026