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

September 3, 2018 updated by: IVI Sevilla

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41011
        • IVI Sevilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 14 months
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 14 months
14 months
Embryo quality
Time Frame: 14 months
According to ASEBIR criteria
14 months
Implantation rate
Time Frame: 14 months
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Sevilla

Investigators

  • Principal Investigator: Rocío Quiroga, MSc, IVI Sevilla
  • Study Chair: Cristina González, PhD, IVI Sevilla
  • Study Chair: Cinzia Caligara, MD, IVI Sevilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (ESTIMATE)

July 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IVISEV-004ROVIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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