NCT01265329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2.2 years

First QC Date

October 8, 2010

Last Update Submit

August 4, 2014

Conditions

Sperm Selection

Outcome Measures

Primary Outcomes (1)

  • Gestation

    Sperm selection and blood sample confirming gestation

    14 days

Study Arms (2)

Control

NO INTERVENTION

No sperm selection

Annexine V negative

EXPERIMENTAL

Sperm selection with Annexine V protein

Other: Negative selection

Interventions

Negative selectionOTHER

Sperm selection to continue the treatment with healthy sperm

Annexine V negative

Eligibility Criteria

Age18 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, Valencia, 46015, Spain

Location

Study Officials

  • Nicolas Garrido, PhD

    IVI Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Embryologist IVI Valencia

Study Record Dates

First Submitted

October 8, 2010

First Posted

December 23, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

ES(1)