NCT02708537

Brief Summary

The hypothesis is growing semen samples with plasma rich in growth factors (PRGF), because it could improve sperm motility in patients subsidiary TRA, ultimately improving pregnancy rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

March 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

March 4, 2016

Last Update Submit

July 29, 2022

Conditions

Vascular Endothelial Growth Factor Overexpression

Outcome Measures

Primary Outcomes (1)

  • Evaluate the percentage of motile sperm adding PRGF versus those samples that growth factors were not added

    Within concerted donor visits in IVI Bilbao will be held: * Removing Blood 9 mL of blood to obtain plasma rich in factors growth * Seminogram to analyze all semen parameters according to the criteria of the WHO (2010), paying particular attention to sperm motility. * Sperm vitality will be analyzed before and after treatment with PRGF. PRGF application on the seminal aliquots will be conducted at different concentrations assessing sperm motility.

    6 months

Study Arms (1)

PRGF in candidates for sperm donors

Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.

Biological: PRGF in candidates for sperm donors

Interventions

PRGF in candidates for sperm donorsBIOLOGICAL

PRGF application on seminal aliquots will be conducted at different concentrations assessing sperm motility.

PRGF in candidates for sperm donors

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.

You may qualify if:

  • years
  • more than 5 million sperm per milliliter

You may not qualify if:

  • Not having genetic and infectious diseases
  • Do not suffer mental illness
  • Have a family study determined that there is no risk of hereditary diseases
  • There have fathered more than 6 children in the country

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IVI Bilbao

Leioa, Vizcaya, 48011, Spain

Location

IVI Bilbao

Leioa, Vizcaya, 48940, Spain

Location

BTI

Vitoria-Gasteiz, Spain

Location

Study Officials

  • Marcos Ferrando

    IVI Bilbao

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 15, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

December 1, 2017

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

share data to BTI

Locations

ES(3)