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Methods for Objective Selection of Competent Sperm (MACS)

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ClinicalTrials.gov Identifier: NCT01265329
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Sperm Selection Other: Negative selection

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Gestation [ Time Frame: 14 days ]
    Sperm selection and blood sample confirming gestation


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265329


Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Principal Investigator: Nicolas Garrido, PhD IVI Valencia
More Information

Responsible Party: Marcos Meseguer, Embryologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01265329     History of Changes
Other Study ID Numbers: 0810-C-051-MM
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014