Application of MACS and Time-lapse Technology in Good-prognosis Patients
|ClinicalTrials.gov Identifier: NCT01908569|
Recruitment Status : Recruiting
First Posted : July 25, 2013
Last Update Posted : November 14, 2017
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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).
The sperm will be subjected to capacitation through a density gradient together with the MACS technique in order to select the non-apoptotic spermatozoids.
- Clinical pregnancy rate [ Time Frame: 14 months ]
- Pregnancy rate [ Time Frame: 14 months ]
- Embryo quality [ Time Frame: 14 months ]According to ASEBIR criteria
- Implantation rate [ Time Frame: 14 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908569
|Contact: Victor Blasco, MScfirstname.lastname@example.org|
|Contact: Nicolás Prados, PhDemail@example.com|
|Seville, Spain, 41011|
|Contact: Victor Blasco, MSc +34954286274 firstname.lastname@example.org|
|Contact: Nicolás Prados, PhD +34954289274 email@example.com|
|Sub-Investigator: Victor Blasco, MSc|
|Principal Investigator: Rocío Quiroga, MSc|
|Sub-Investigator: Cinzia Caligara, MD|
|Sub-Investigator: Cristina González, PhD|
|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|