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

Not Applicable

Terminated

• Conditions: MACS Technique Efficacy
• Interventions: Other: NO MACS; Other: MACS

• Registration Number: NCT01908569
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NO MACS + Time-lapse technology	NO MACS	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).
MACS + time-lapse technology	MACS	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).

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	14 months

Secondary Outcome Measures

Name	Time	Method
Implantation rate	14 months
Pregnancy rate	14 months
Embryo quality	14 months	According to ASEBIR criteria

Trial Locations

Locations (1)

IVI Sevilla; 🇪🇸 Seville, Spain