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Effect of Plasma Rich in Growth Factors on Semen Quality

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ClinicalTrials.gov Identifier: NCT02708537
Recruitment Status : Completed
First Posted : March 15, 2016
Last Update Posted : August 1, 2022
Sponsor:
Collaborator:
bTI Vitoria
Information provided by (Responsible Party):
IVI Bilbao

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.

Condition or disease Intervention/treatment
Vascular Endothelial Growth Factor Overexpression Biological: PRGF in candidates for sperm donors

Detailed Description:

Platelet growth factors are a group of proteins involved in cellular communication modifying biological responses. Obtaining plasma rich in growth factors is already widespread and simple protocol technique that is being used in various areas of medicine with superb results. Described many of the growth factors present in the PRGF are related to sperm parameters, especially motility The described effects have been studied in mammalian and each growth factor individually. PRGF contains a pool of growth factors and therefore be interesting to analyze their effect on various sperm parameters.

One of those parameters is very important for fertilization sperm motility, since the lack of it will prevent displacement by the cervix to meet the egg in the fallopian tube.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Plasma Rich in Growth Factors (PRGF) on Semen Quality
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2017

Group/Cohort Intervention/treatment
PRGF in candidates for sperm donors
Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.
Biological: PRGF in candidates for sperm donors
PRGF application on seminal aliquots will be conducted at different concentrations assessing sperm motility.




Primary Outcome Measures :
  1. Evaluate the percentage of motile sperm adding PRGF versus those samples that growth factors were not added [ Time Frame: 6 months ]

    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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.
Criteria

Inclusion Criteria:

  • 18-35 years
  • more than 5 million sperm per milliliter

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708537


Locations
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Spain
IVI Bilbao
Leioa, Vizcaya, Spain, 48011
IVI Bilbao
Leioa, Vizcaya, Spain, 48940
BTI
Vitoria, Spain
Sponsors and Collaborators
IVI Bilbao
bTI Vitoria
Investigators
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Study Director: Marcos Ferrando IVI Bilbao
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Responsible Party: IVI Bilbao
ClinicalTrials.gov Identifier: NCT02708537    
Other Study ID Numbers: 1411-BIO-081-MF
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: share data to BTI