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

I

IVI Sevilla

Status

Terminated

Conditions

MACS Technique Efficacy

Treatments

Other: NO MACS
Other: MACS

Study type

Interventional

Funder types

Other

Identifiers

NCT01908569
IVISEV-004ROVIC

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

Female

Ages

18 to 38 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

NO MACS + Time-lapse technology
Active Comparator group
Description:
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).
Treatment:
Other: NO MACS
MACS + time-lapse technology
Experimental group
Description:
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).
Treatment:
Other: MACS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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