Methods for Objective Selection of Competent Sperm

NCT ID: NCT01265329

Last Updated: 2014-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sperm Selection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

No sperm selection

Group Type NO_INTERVENTION

No interventions assigned to this group

Annexine V negative

Sperm selection with Annexine V protein

Group Type EXPERIMENTAL

Negative selection

Intervention Type OTHER

Sperm selection to continue the treatment with healthy sperm

Interventions

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Negative selection

Sperm selection to continue the treatment with healthy sperm

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

MEN:

\- \>3million sperm after swimming process

WOMEN:

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

Exclusion Criteria

* NONE
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Marcos Meseguer

Embryologist IVI Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Garrido, PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

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IVI Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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0810-C-051-MM

Identifier Type: -

Identifier Source: org_study_id

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