Autologous Platelet-rich Plasma SupplementNCT06258759
The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation on Post-cryopreserved Sperm Quality
A study testing autologous platelet-rich plasma supplement and no autologous platelet-rich plasma supplement in people with Autologous Platelet-rich Plasma Supplement and Sperm Cryopreservation, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Sperm cryopreservation is an essential procedure for male fertility in certain situations, like cancer, vasectomy or other obstructive surgeries, autoimmunity diseases, immunosuppressive therapeutic strategies, or when the male partner is incapable of providing sufficient spermatozoa on the day of egg retrieval. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autologous Platelet-rich Plasma Supplement, Sperm Cryopreservation, Post-cryopreserved Sperm Quality
- What is being tested?
- autologous platelet-rich plasma supplement and no autologous platelet-rich plasma supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A man who be a Rajavithi hospital clients or staff.
- Aged 20-40 years old.
- Has normal semen analysis.
- Can communicate and understand Thai language very well.
- Voluntarily participated in the research.
- Sexual abstinence for 2-7 days.
Who cannot join
- A man who ever diagnosed with infertile patient.
- A wan who diagnosed with any hematological disease such as Coagulation disorders, Hypertension, Thrombocytopenia, Platelet dysfunction.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rajavithi hospital
Bangkok, 10400
Choermin Thitipatlertdech, +6692-2659265, choermin@hotmail.com
Nisanart Booning, +6684-1653945, tobee_b@hotmail.com
About this study
Official title: The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation
Sperm cryopreservation is an essential procedure for male fertility in certain situations, like cancer, vasectomy or other obstructive surgeries, autoimmunity diseases, immunosuppressive therapeutic strategies, or when the male partner is incapable of providing sufficient spermatozoa on the day of egg retrieval. Semen cryopreservation is mainly associated with decreased viability, motility, and DNA damage of spermatozoa due to the osmotic and mechanical stresses attributed to the freezing-thaw- ing process. Sperm cryodamage mainly originates from osmotic changes, cold shock, intracellular ice crystal formation, and oxidative stress. Based on this, some protective strategies have been proposed and developed, even the addition of cryoprotectants. Recently, Platelet-rich plasma (PRP) is becoming very popular in medicine. The therapeutic effect of platelets is related to alpha granule contents. A study showed that PRP modulates ROS toxicity through a different mechanism. VEGF detoxify oxidative damage via activation of the nuclear factor (erythroid- derived 2)-like2 (Nrf2) pathway. Oxidative stress modulation and apoptosis inhibition both have an essential role during the cryopreservation process. In this case, it raises the question of whether PRP can improve the sperm quality against freeze-thawing-induced damage. Therefore, the present study aimed to examine different concentrations of PRP on frozen-thawed sperm parameters of vitality, morphology, motility and DNA fragmentation
Read the detailed description
- Each participant will be collected a semen and PRP.
- Each semen will be separated into two specimens as the additional autologous platelet-rich plasma supplement group and control group (no adding autologous platelet-rich plasma). Both groups will undergo cryopreservation by Sperm vitrification for 14 days.
- The additional autologous platelet-rich plasma supplement group: the semen will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
- The control group (no adding autologous platelet-rich plasma): the semen will be mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
- After 14 days, the vitrified semen was transferred to a water bath of 37 °C for thawing. And analyzed Semen analysis via Computer Assisted Sperm Analysis: CASA and analyzed DNA fragmentation
- Conditions
- Autologous Platelet-rich Plasma Supplement, Sperm Cryopreservation, Post-cryopreserved Sperm Quality, Semen Analysis
- Being tested
- autologous platelet-rich plasma supplement, no autologous platelet-rich plasma supplement
- Keywords
- Sperm, Platelet rich plasma, Vitrification, Cryopreservation, Semen analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet-rich plasma supplementBiological
the semen of the additional autologous platelet-rich plasma supplement group will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days
no autologous platelet-rich plasma supplementBiological
the semen mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days
| Study group | Role | What they receive |
|---|---|---|
| experimental: semen | Experimental | a semen of normal semen analysis Receives: Biological: autologous platelet-rich plasma supplement |
| placebo: semen | Experimental | a semen of normal semen analysis Receives: Biological: no autologous platelet-rich plasma supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm vitality
Sperm vitality (percentage) after thawing
Measured: 14 days after cryopreservation
Secondary outcomes (3)
Sperm motility
Sperm motility (percentage) after thawing
Measured: 14 days after cryopreservation
Sperm morphology
Sperm morphology (percentage of normal form) after thawing
Measured: 14 days after cryopreservation
DNA fragmentation
DNA fragmentation (percentage) after thawing
Measured: 14 days after cryopreservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Platelet-rich Plasma SupplementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258759
- Sponsor's protocol ID
- 151/2566
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: drafting official document and distribute to IPD about study protocal, statistical analysis plan. inform consent and clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation
- ClinicalTrials.gov ID
- NCT06258759
- Acronym / sponsor ID
- 151/2566
- Conditions
- Autologous Platelet-rich Plasma Supplement, Sperm Cryopreservation, Post-cryopreserved Sperm Quality, Semen Analysis
- Keywords
- Sperm, Platelet rich plasma, Vitrification, Cryopreservation, Semen analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- 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.
Sperm cryopreservation is an essential procedure for male fertility in certain situations, like cancer, vasectomy or other obstructive surgeries, autoimmunity diseases, immunosuppressive therapeutic strategies, or when the male partner is incapable of providing sufficient spermatozoa on the day of egg retrieval. Semen cryopreservation is mainly associated with decreased viability, motility, and DNA damage of spermatozoa due to the osmotic and mechanical stresses attributed to the freezing-thaw- ing process. Sperm cryodamage mainly originates from osmotic changes, cold shock, intracellular ice crystal formation, and oxidative stress. Based on this, some protective strategies have been proposed and developed, even the addition of cryoprotectants. Recently, Platelet-rich plasma (PRP) is becoming very popular in medicine. The therapeutic effect of platelets is related to alpha granule contents. A study showed that PRP modulates ROS toxicity through a different mechanism. VEGF detoxify oxidative damage via activation of the nuclear factor (erythroid- derived 2)-like2 (Nrf2) pathway. Oxidative stress modulation and apoptosis inhibition both have an essential role during the cryopreservation process. In this case, it raises the question of whether PRP can improve the sperm quality against freeze-thawing-induced damage. Therefore, the present study aimed to examine different concentrations of PRP on frozen-thawed sperm parameters of vitality, morphology, motility and DNA fragmentation
Detailed description
- Each participant will be collected a semen and PRP.
- Each semen will be separated into two specimens as the additional autologous platelet-rich plasma supplement group and control group (no adding autologous platelet-rich plasma). Both groups will undergo cryopreservation by Sperm vitrification for 14 days.
- The additional autologous platelet-rich plasma supplement group: the semen will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
- The control group (no adding autologous platelet-rich plasma): the semen will be mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
- After 14 days, the vitrified semen was transferred to a water bath of 37 °C for thawing. And analyzed Semen analysis via Computer Assisted Sperm Analysis: CASA and analyzed DNA fragmentation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental: semen | Experimental | Biological: autologous platelet-rich plasma supplementa semen of normal semen analysis |
| placebo: semen | Experimental | Biological: no autologous platelet-rich plasma supplementa semen of normal semen analysis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A man who be a Rajavithi hospital clients or staff.
- Aged 20-40 years old.
- Has normal semen analysis.
- Can communicate and understand Thai language very well.
- Voluntarily participated in the research.
Key exclusion criteria (2 listed)
- A man who ever diagnosed with infertile patient.
- A wan who diagnosed with any hematological disease such as Coagulation disorders, Hypertension, Thrombocytopenia, Platelet dysfunction.
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 |
|---|---|---|
| autologous platelet-rich plasma supplementthe semen of the additional autologous platelet-rich plasma supplement group will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days | Biological | experimental: semen |
| no autologous platelet-rich plasma supplementthe semen mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days | Biological | placebo: semen |
Primary outcome
Sperm vitality
Time frame: 14 days after cryopreservation
Sperm vitality (percentage) after thawing
3 secondary outcomes
Sperm motility
Time frame: 14 days after cryopreservation
Sperm morphology
Time frame: 14 days after cryopreservation
DNA fragmentation
Time frame: 14 days after cryopreservation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: Yes. drafting official document and distribute to IPD about study protocal, statistical analysis plan. inform consent and clinical study report
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous platelet-rich plasma supplement and no autologous platelet-rich plasma supplement in people with Autologous Platelet-rich Plasma Supplement and Sperm Cryopreservation, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choermin Thitipatlertdech, M.D. (+6692-2659265, choermin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm vitality (time frame: 14 days after cryopreservation). 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 14 Feb 2024.