Methods for Objective Selection of Competent Sperm

Sperm Selection Clinical Trial

— MACS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265329
• Other study ID #: 0810-C-051-MM
• Status: Completed
• Phase: N/A
• First received: October 8, 2010
• Last updated: August 4, 2014
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

MEN:

• >3million sperm after swimming process

WOMEN:

• < 37 YEARS OLD

• NO GYNECOLOGICAL ANOMOLIES

• HORMONAL VALUES WITHIN CLINICAL RANGE

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Sperm Selection

Intervention

Other:
• Negative selection
Sperm selection to continue the treatment with healthy sperm

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestation	Sperm selection and blood sample confirming gestation	14 days	No