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Methods for Objective Selection of Competent Sperm (MACS)

This study is currently recruiting participants.
Verified April 2012 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by (Responsible Party):
Marcos Meseguer, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01265329
First received: October 8, 2010
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

In spite of the achievements and developement of the assisted reproduction techniques in the last years, there is still an elevated percentage of unsuccessful treatments, needing sometimes repeated attempts to reach pregnancy.

The molecular physiology of sperm is being better characterized, and some reports have demonstrated the implication of different molecular processes in the pathophysiology of male infertility.

Recently, different sperm selection methods have been based on these molecular differences, showing a better quality of the sperm population after selection.

The main objective of this research project is to clinically apply these techniques in order to increase the pregnancy rates per cycle in infertile couples attending assisted reproduction treatments.


Condition Intervention
Sperm Selection
 Other: Negative selection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Gestation [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Sperm selection and blood sample confirming gestation


Estimated Enrollment: 275
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No sperm selection
Experimental: Annexine V negative
Sperm selection with Annexine V protein
 Other: Negative selection
Sperm selection to continue the treatment with healthy sperm

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

MEN:

- >3million sperm after swimming process

WOMEN:

  • < 37 YEARS OLD
  • NO GYNECOLOGICAL ANOMOLIES
  • HORMONAL VALUES WITHIN CLINICAL RANGE

Exclusion Criteria:

  • NONE
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265329

Contacts
Contact: Laura Romany lromany@ivi.es
Contact: Leslie Atkinson latkinson@ivi.es

Locations
Spain
IVI Valencia Not yet recruiting
Valencia, Spain, 46015
Contact: Leslie Atkinson         latkinson@ivi.es    
Sub-Investigator: Laura Romany            
IVI Valencia Recruiting
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Nicolas Garrido, PhD IVI Valencia
  More Information

No publications provided

Responsible Party: Marcos Meseguer, Embryologist IVI Valencia, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01265329     History of Changes
Other Study ID Numbers: 0810-C-051-MM
Study First Received: October 8, 2010
Last Updated: April 27, 2012
Health Authority: Spain: Ministry of Health

ClinicalTrials.gov processed this record on May 23, 2013