Vascular Endothelial Growth Factor OverexpressionNCT02708537
Effect of Plasma Rich in Growth Factors on Semen Quality
An observational study of Vascular Endothelial Growth Factor Overexpression, run by IVI Bilbao at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Endothelial Growth Factor Overexpression
- What is being tested?
- PRGF in candidates for sperm donors
- How many people
- 20 participants
- Where
- 3 sitesSpain
- Study dates
- Apr 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.
Who may be able to join
- 18-35 years
- more than 5 million sperm per milliliter
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
IVI Bilbao
Leioa, Vizcaya, 48011
IVI Bilbao
Leioa, Vizcaya, 48940
BTI
Vitoria-Gasteiz
About this study
Official title: Effect of Plasma Rich in Growth Factors (PRGF) on Semen Quality
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.
Read the 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.
- Being tested
- PRGF in candidates for sperm donors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF in candidates for sperm donorsBiological
PRGF application on seminal aliquots will be conducted at different concentrations assessing sperm motility.
| Study group | Role | What they receive |
|---|---|---|
| PRGF in candidates for sperm donors | Prospective study of 58 candidates for sperm donors clinic IVI Bilbao. Receives: Biological: PRGF in candidates for sperm donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Endothelial Growth Factor OverexpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Bilbao
- Sponsor type
- University, hospital or other
- Collaborators
- bTI Vitoria
- Responsible party
- Sponsor
- Investigators
- Marcos Ferrando, Study director, IVI Bilbao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708537
- Sponsor's protocol ID
- 1411-BIO-081-MF
- Status last verified
- Jul 2022
- First submitted
- 4 Mar 2016
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: share data to BTI
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plasma Rich in Growth Factors (PRGF) on Semen Quality
- ClinicalTrials.gov ID
- NCT02708537
- Acronym / sponsor ID
- 1411-BIO-081-MF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Collaborators
- bTI Vitoria
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRGF in candidates for sperm donors | – | Biological: PRGF in candidates for sperm donorsProspective study of 58 candidates for sperm donors clinic IVI Bilbao. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.
Key inclusion criteria (2 listed)
- 18-35 years
- more than 5 million sperm per milliliter
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRGF in candidates for sperm donorsPRGF application on seminal aliquots will be conducted at different concentrations assessing sperm motility. | Biological | PRGF in candidates for sperm donors |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: Yes. share data to BTI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcos Ferrando study director
IVI Bilbao
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Endothelial Growth Factor Overexpression, run by IVI Bilbao at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the percentage of motile sperm adding PRGF versus those samples that growth factors were not added (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.