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Effect of Plasma Rich in Growth Factors on Semen Quality

Sponsor
IVI Bilbao (Other)
Overall Status
Completed
CT.gov ID
NCT02708537
Collaborator
bTI Vitoria (Other)
20
Enrollment
3
Locations
20
Actual Duration (Months)
6.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Apr 1, 2016
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IVI Bilbao Leioa Vizcaya Spain 48011
2 IVI Bilbao Leioa Vizcaya Spain 48940
3 BTI Vitoria Spain

Sponsors and Collaborators

  • IVI Bilbao
  • bTI Vitoria

Investigators

  • Study Director: Marcos Ferrando, IVI Bilbao

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IVI Bilbao
ClinicalTrials.gov Identifier:
NCT02708537
Other Study ID Numbers:
  • 1411-BIO-081-MF
First Posted:
Mar 15, 2016
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes

Study Results

No Results Posted as of Aug 1, 2022