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

MACS Technique Efficacy Clinical Trial

Official title:

Application of MACS (Magnetic-activated Cell Sorting) and Time-lapse Technology (Embryoscope) in Assisted Reproduction Patients With Good Prognosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01908569
• Other study ID #: IVISEV-004ROVIC
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: November 2016

Study information

• Verified date: September 2018
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• MACS Technique Efficacy

Intervention

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.
• NO MACS
The sperm capacitation will be performed through a density gradient. The MACS technique will not be applied.

Locations

Country	Name	City	State
Spain	IVI Sevilla	Seville

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		14 months
Secondary	Pregnancy rate		14 months
Secondary	Embryo quality	According to ASEBIR criteria	14 months
Secondary	Implantation rate		14 months