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

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ClinicalTrials.gov Identifier: NCT01908569
Recruitment Status : Recruiting
First Posted : July 25, 2013
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
IVI Sevilla

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.


Condition or disease Intervention/treatment Phase
MACS Technique Efficacy Other: MACS Other: NO MACS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Application of MACS (Magnetic-activated Cell Sorting) and Time-lapse Technology (Embryoscope) in Assisted Reproduction Patients With Good Prognosis
Study Start Date : July 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: NO MACS + Time-lapse technology
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
The sperm capacitation will be performed through a density gradient. The MACS technique will not be applied.
Experimental: MACS + time-lapse technology
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
The sperm will be subjected to capacitation through a density gradient together with the MACS technique in order to select the non-apoptotic spermatozoids.



Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 14 months ]

Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 14 months ]
  2. Embryo quality [ Time Frame: 14 months ]
    According to ASEBIR criteria

  3. Implantation rate [ Time Frame: 14 months ]


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908569


Contacts
Contact: Victor Blasco, MSc +34954286274 victor.blasco@ivi.es
Contact: Nicolás Prados, PhD +34954286274 nicolas.prados@ivi.es

Locations
Spain
IVI Sevilla Recruiting
Seville, Spain, 41011
Contact: Victor Blasco, MSc    +34954286274    victor.blasco@ivi.es   
Contact: Nicolás Prados, PhD    +34954289274    nicolas.prados@ivi.es   
Sub-Investigator: Victor Blasco, MSc         
Principal Investigator: Rocío Quiroga, MSc         
Sub-Investigator: Cinzia Caligara, MD         
Sub-Investigator: Cristina González, PhD         
Sponsors and Collaborators
IVI Sevilla
Investigators
Study Chair: Victor Blasco, MSc IVI Sevilla
Principal Investigator: Rocío Quiroga, MSc IVI Sevilla
Study Chair: Cristina González, PhD IVI Sevilla
Study Chair: Cinzia Caligara, MD IVI Sevilla

Responsible Party: IVI Sevilla
ClinicalTrials.gov Identifier: NCT01908569     History of Changes
Other Study ID Numbers: IVISEV-004ROVIC
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by IVI Sevilla:
MACS, time-lapse, embryo, spermatozoid, sperm