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

NCT01908569 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-09-05

No results posted yet for this study

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.

Conditions

  • MACS Technique Efficacy

Interventions

OTHER

MACS

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

OTHER

NO MACS

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

Sponsors & Collaborators

  • Vida Recoletas Sevilla

    lead OTHER

Principal Investigators

  • Victor Blasco, MSc · Vida Recoletas Sevilla

  • Rocío Quiroga, MSc · Vida Recoletas Sevilla

  • Cristina González, PhD · Vida Recoletas Sevilla

  • Cinzia Caligara, MD · Vida Recoletas Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01908569 on ClinicalTrials.gov