Methods for Objective Selection of Competent Sperm (MACS)

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.

Study Overview

• Status: Completed
• Conditions: Sperm Selection
• Intervention / Treatment: Other: Negative selection

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • IVI Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

MEN:

- >3million sperm after swimming process

WOMEN:

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

Exclusion Criteria:

• NONE

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestation	Sperm selection and blood sample confirming gestation	14 days

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Investigators: Principal Investigator: Nicolas Garrido, PhD, IVI Valencia

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 0810-C-051-MM