NCT01908569

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

3.3 years

First QC Date

July 23, 2013

Last Update Submit

September 3, 2018

Conditions

MACS Technique Efficacy

Keywords

MACS, time-lapse, embryo, spermatozoid, sperm

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    14 months

Secondary Outcomes (3)

  • Pregnancy rate

    14 months

  • Embryo quality

    14 months

  • Implantation rate

    14 months

Study Arms (2)

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).

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).

Other: MACS

Interventions

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.

MACS + time-lapse technology
NO MACSOTHER

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

NO MACS + Time-lapse technology

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients subject to preimplantation genetic diagnosis treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Sevilla

Seville, 41011, Spain

Location

Study Officials

  • Victor Blasco, MSc

    Vida Recoletas Sevilla

    STUDY CHAIR

  • Rocío Quiroga, MSc

    Vida Recoletas Sevilla

    PRINCIPAL INVESTIGATOR

  • Cristina González, PhD

    Vida Recoletas Sevilla

    STUDY CHAIR

  • Cinzia Caligara, MD

    Vida Recoletas Sevilla

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

ES(1)