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Clinical Trials/NCT01265329
NCT01265329CompletedNot Applicable

Methods for Objective Selection of Competent Sperm

Instituto Valenciano de Infertilidad, IVI VALENCIA1 site in 1 country237 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
237
Locations
1
Primary Endpoint
Gestation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 37 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •>3million sperm after swimming process
  • •< 37 YEARS OLD
  • •NO GYNECOLOGICAL ANOMOLIES
  • •HORMONAL VALUES WITHIN CLINICAL RANGE

Exclusion Criteria

  • Not provided

Arms & Interventions

Control

No Intervention

No sperm selection

Annexine V negative

Experimental

Sperm selection with Annexine V protein

Intervention: Negative selection (Other)

Outcomes

Primary Outcomes

Gestation

Time Frame: 14 days

Sperm selection and blood sample confirming gestation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marcos Meseguer

Embryologist IVI Valencia

Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Sites (1)

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