Sperm CryodamagePRPNCT07504575
Effect of PRP in Donor Semen During Cryoprervation
An observational study of Sperm Cryodamage, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.
Trial summary
Sperm cryopreservation allows the preservation of sperm biological function for long periods of time for later use in assisted reproductive techniques (ART). However, the freezing and thawing process causes structural and functional damage to sperm, leading to decreased motility and vitality, a loss of plasma membrane… 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
- Sperm Cryodamage
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2026to 30 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of semen donors between 18 and 35 years old who attend the IVI Alicante center during the study period, and who have been verified to meet the inclusion/exclusion criteria.
Who may be able to join
- Age from 18 to 35 years
- Concentration higher than 50 million progressively motile sperm.
- Morphology: more than 4% normal sperm shapes.
Who cannot join
- Presence of personal or hereditary pathology.
- Presence of psychological or behavioral disorder.
- Semen parameters below those indicated in the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IVI Alicante
Alicante, Alicante, 03015
Elena Sellés, PhD, +34 966012490 ext. 13503, elena.selles@ivirma.com
About this study
Official title: Effect of Platelet-rich Plasma (PRP) on the Quality of Donor Semen During Cryopreservation
Sperm cryopreservation allows the preservation of sperm biological function for long periods of time for later use in assisted reproductive techniques (ART). However, the freezing and thawing process causes structural and functional damage to sperm, leading to decreased motility and vitality, a loss of plasma membrane integrity and even DNA damage.
In recent years, various strategies have been studied to protect sperm from cryodamage, including the optimization of freezing processes, the design of freezing devices, and improved freezing media.
One possible measure to mitigate the cryodamage suffered by sperm is the addition of PRP, or platelet-rich plasma, to the freezing medium. In previous studies, PRP components have been shown to have positive effects on semen quality, improving motility, viability, and plasma membrane integrity after cryopreservation. In light of these positive results, this study will evaluate the possibility of incorporating PRP into sperm cryopreservation media and its potential future benefits for patients and clinical outcomes. To this end, each semen sample after a previous spermiogram will be aliquoted, and 0%, 1%, 2%, and 5% PRP will be added to the cryopreservation medium according to the sperm group to which the belong. A spermiogram will be performed after cryopreservation to assess various semen quality parameters, including sperm count, motility, morphology, vitality, and chromatin dispersion. The data must be processed through statistical analysis to obtain results that allow determining, primarily, whether there is a beneficial effect on sperm quality after sperm motility and sperm during cryopreservation with the addition of PRP.
Read the detailed description
The main objective of this study will be to detect whether there is a significant difference in progressive mobility between the control group and the cryopreserved samples with 5% autologous PRP.
The secondary objectives will be as follows:
Detect significant differences in progressive mobility between the control group and the cryopreserved samples with autologous PRP at concentrations of 1% or 2%; Determine if there are significant differences in the values of the semen quality parameters according to the categorical concentration of PRP used in cryopreservation.; Determine if there is a correlation between the numerical concentration of PRP and the semen quality parameters; Check if the platelet count, that is, the concentration of platelets present in the autologous plasma which has a higher concentration of platelets than the original sample, is correlated with the semen parameters analyzed post-thawing.
- Conditions
- Sperm Cryodamage
- Keywords
- Sperm, PRP, Cryopreservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | No PRP treatment | |
| 1% | 1% PRP treatment | |
| 2% | 2% PRP treatment | |
| 5% | 5% PRP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive sperm motility after thawing
Percentage of progressively motile spermatozoa in semen samples after cryopreservation, comparing control samples with samples cryopreserved with 5% autologous platelet-rich plasma (PRP).
Measured: Immediately after thawing of the semen samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start10 Feb 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Sperm CryodamageStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Sellés Soriano, Instituto Valenciano de Infertilidad, IVI Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504575
- Sponsor's protocol ID
- 2503-ALC-038-ES
- Acronym
- PRP
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yildiz C, Ottaviani P, Law N, Ayearst R, Liu L, McKerlie C. Effects of cryopreservation on sperm quality, nuclear DNA integrity, in vitro fertilization, and in vitro embryo development in the mouse. Reproduction. 2007 Mar;133(3):585-95. doi: 10.1530/REP-06-0256.
PubMed 17379653Yang C, Xu L, Cui Y, Wu B, Liao Z. Potent humanin analogue (HNG) protects human sperm from freeze-thaw-induced damage. Cryobiology. 2019 Jun;88:47-53. doi: 10.1016/j.cryobiol.2019.04.001. Epub 2019 Apr 6.
PubMed 30959025Yan B, Zhang Y, Tian S, Hu R, Wu B. Effect of autologous platelet-rich plasma on human sperm quality during cryopreservation. Cryobiology. 2021 Feb;98:12-16. doi: 10.1016/j.cryobiol.2021.01.009. Epub 2021 Jan 19.
PubMed 33476642Verza S Jr, Feijo CM, Esteves SC. Resistance of human spermatozoa to cryoinjury in repeated cycles of thaw-refreezing. Int Braz J Urol. 2009 Sep-Oct;35(5):581-90; discussion 591. doi: 10.1590/s1677-55382009000500010.
PubMed 19860937Sztein JM, Noble K, Farley JS, Mobraaten LE. Comparison of permeating and nonpermeating cryoprotectants for mouse sperm cryopreservation. Cryobiology. 2001 Feb;42(1):28-39. doi: 10.1006/cryo.2001.2300.
PubMed 11336487Starmer BZ, Baird A, Lucky MA. Considerations in fertility preservation in cases of testicular trauma. BJU Int. 2018 Mar;121(3):466-471. doi: 10.1111/bju.14084. Epub 2017 Dec 10.
PubMed 29164757Shokri S, Ebrahimi SM, Ziaeipour S, Nejatbakhsh R. Effect of insulin on functional parameters of human cryopreserved sperms. Cryobiology. 2019 Apr;87:68-73. doi: 10.1016/j.cryobiol.2019.02.002. Epub 2019 Feb 11.
PubMed 30763565Selvaraju S, Krishnan BB, Archana SS, Ravindra JP. IGF1 stabilizes sperm membrane proteins to reduce cryoinjury and maintain post-thaw sperm motility in buffalo (Bubalus bubalis) spermatozoa. Cryobiology. 2016 Aug;73(1):55-62. doi: 10.1016/j.cryobiol.2016.05.012. Epub 2016 May 30.
PubMed 27256665Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.
PubMed 35175511Saucedo L, Buffa GN, Rosso M, Guillardoy T, Gongora A, Munuce MJ, Vazquez-Levin MH, Marin-Briggiler C. Fibroblast Growth Factor Receptors (FGFRs) in Human Sperm: Expression, Functionality and Involvement in Motility Regulation. PLoS One. 2015 May 13;10(5):e0127297. doi: 10.1371/journal.pone.0127297. eCollection 2015.
PubMed 25970615Said TM, Gaglani A, Agarwal A. Implication of apoptosis in sperm cryoinjury. Reprod Biomed Online. 2010 Oct;21(4):456-62. doi: 10.1016/j.rbmo.2010.05.011. Epub 2010 Jun 1.
PubMed 20800544Padilha RT, Magalhaes-Padilha DM, Cavalcante MM, Almeida AP, Haag KT, Gastal MO, Nunes JF, Rodrigues AP, Figueiredo JR, Oliveira MA. Effect of insulin-like growth factor-I on some quality traits and fertility of cryopreserved ovine semen. Theriogenology. 2012 Sep 1;78(4):907-13. doi: 10.1016/j.theriogenology.2012.04.005. Epub 2012 Apr 27.
PubMed 22541171Nabavinia MS, Yari A, Ghasemi-Esmailabad S, Gholoobi A, Gholizadeh L, Nabi A, Lotfi M, Khalili MA. Improvement of human sperm properties with platelet-rich plasma as a cryoprotectant supplement. Cell Tissue Bank. 2023 Jun;24(2):307-315. doi: 10.1007/s10561-022-10032-6. Epub 2022 Sep 8.
PubMed 36074213Mirzaei J, Movahedin M, Halvaei I. Plasma-Rich in Growth Factors Ameliorates Detrimental Effects of Cryopreservation on Human Sperm: A Prospective Study. Cell J. 2022 Jun;24(6):330-336. doi: 10.22074/cellj.2022.8119. Epub 2022 Jun 29.
PubMed 35892237McNicol A, Israels SJ. Platelet dense granules: structure, function and implications for haemostasis. Thromb Res. 1999 Jul 1;95(1):1-18. doi: 10.1016/s0049-3848(99)00015-8.
PubMed 10403682
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet-rich Plasma (PRP) on the Quality of Donor Semen During Cryopreservation
- ClinicalTrials.gov ID
- NCT07504575
- Acronym / sponsor ID
- PRP / 2503-ALC-038-ES
- Conditions
- Sperm Cryodamage
- Keywords
- Sperm, PRP, Cryopreservation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI AlicanteUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 1 Apr 2026 (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 allows the preservation of sperm biological function for long periods of time for later use in assisted reproductive techniques (ART). However, the freezing and thawing process causes structural and functional damage to sperm, leading to decreased motility and vitality, a loss of plasma membrane integrity and even DNA damage.
In recent years, various strategies have been studied to protect sperm from cryodamage, including the optimization of freezing processes, the design of freezing devices, and improved freezing media.
One possible measure to mitigate the cryodamage suffered by sperm is the addition of PRP, or platelet-rich plasma, to the freezing medium. In previous studies, PRP components have been shown to have positive effects on semen quality, improving motility, viability, and plasma membrane integrity after cryopreservation. In light of these positive results, this study will evaluate the possibility of incorporating PRP into sperm cryopreservation media and its potential future benefits for patients and clinical outcomes. To this end, each semen sample after a previous spermiogram will be aliquoted, and 0%, 1%, 2%, and 5% PRP will be added to the cryopreservation medium according to the sperm group to which the belong. A spermiogram will be performed after cryopreservation to assess various semen quality parameters, including sperm count, motility, morphology, vitality, and chromatin dispersion. The data must be processed through statistical analysis to obtain results that allow determining, primarily, whether there is a beneficial effect on sperm quality after sperm motility and sperm during cryopreservation with the addition of PRP.
Detailed description
The main objective of this study will be to detect whether there is a significant difference in progressive mobility between the control group and the cryopreserved samples with 5% autologous PRP.
The secondary objectives will be as follows:
Detect significant differences in progressive mobility between the control group and the cryopreserved samples with autologous PRP at concentrations of 1% or 2%; Determine if there are significant differences in the values of the semen quality parameters according to the categorical concentration of PRP used in cryopreservation.; Determine if there is a correlation between the numerical concentration of PRP and the semen quality parameters; Check if the platelet count, that is, the concentration of platelets present in the autologous plasma which has a higher concentration of platelets than the original sample, is correlated with the semen parameters analyzed post-thawing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | – | –No PRP treatment |
| 1% | – | –1% PRP treatment |
| 2% | – | –2% PRP treatment |
| 5% | – | –5% PRP treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of semen donors between 18 and 35 years old who attend the IVI Alicante center during the study period, and who have been verified to meet the inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- Age from 18 to 35 years
- Concentration higher than 50 million progressively motile sperm.
- Morphology: more than 4% normal sperm shapes.
Key exclusion criteria (3 listed)
- Presence of personal or hereditary pathology.
- Presence of psychological or behavioral disorder.
- Semen parameters below those indicated in the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progressive sperm motility after thawing
Time frame: Immediately after thawing of the semen samples.
Percentage of progressively motile spermatozoa in semen samples after cryopreservation, comparing control samples with samples cryopreserved with 5% autologous platelet-rich plasma (PRP).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 17379653Yildiz C, Ottaviani P, Law N, Ayearst R, Liu L, McKerlie C. Effects of cryopreservation on sperm quality, nuclear DNA integrity, in vitro fertilization, and in vitro embryo development in the mouse. Reproduction. 2007 Mar;133(3):585-95. doi: 10.1530/REP-06-0256.
- Background: PubMed 30959025Yang C, Xu L, Cui Y, Wu B, Liao Z. Potent humanin analogue (HNG) protects human sperm from freeze-thaw-induced damage. Cryobiology. 2019 Jun;88:47-53. doi: 10.1016/j.cryobiol.2019.04.001. Epub 2019 Apr 6.
- Background: PubMed 33476642Yan B, Zhang Y, Tian S, Hu R, Wu B. Effect of autologous platelet-rich plasma on human sperm quality during cryopreservation. Cryobiology. 2021 Feb;98:12-16. doi: 10.1016/j.cryobiol.2021.01.009. Epub 2021 Jan 19.
- Background: PubMed 19860937Verza S Jr, Feijo CM, Esteves SC. Resistance of human spermatozoa to cryoinjury in repeated cycles of thaw-refreezing. Int Braz J Urol. 2009 Sep-Oct;35(5):581-90; discussion 591. doi: 10.1590/s1677-55382009000500010.
- Background: PubMed 11336487Sztein JM, Noble K, Farley JS, Mobraaten LE. Comparison of permeating and nonpermeating cryoprotectants for mouse sperm cryopreservation. Cryobiology. 2001 Feb;42(1):28-39. doi: 10.1006/cryo.2001.2300.
- Background: PubMed 29164757Starmer BZ, Baird A, Lucky MA. Considerations in fertility preservation in cases of testicular trauma. BJU Int. 2018 Mar;121(3):466-471. doi: 10.1111/bju.14084. Epub 2017 Dec 10.
- Background: PubMed 30763565Shokri S, Ebrahimi SM, Ziaeipour S, Nejatbakhsh R. Effect of insulin on functional parameters of human cryopreserved sperms. Cryobiology. 2019 Apr;87:68-73. doi: 10.1016/j.cryobiol.2019.02.002. Epub 2019 Feb 11.
- Background: PubMed 27256665Selvaraju S, Krishnan BB, Archana SS, Ravindra JP. IGF1 stabilizes sperm membrane proteins to reduce cryoinjury and maintain post-thaw sperm motility in buffalo (Bubalus bubalis) spermatozoa. Cryobiology. 2016 Aug;73(1):55-62. doi: 10.1016/j.cryobiol.2016.05.012. Epub 2016 May 30.
- Background: PubMed 35175511Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.
- Background: PubMed 25970615Saucedo L, Buffa GN, Rosso M, Guillardoy T, Gongora A, Munuce MJ, Vazquez-Levin MH, Marin-Briggiler C. Fibroblast Growth Factor Receptors (FGFRs) in Human Sperm: Expression, Functionality and Involvement in Motility Regulation. PLoS One. 2015 May 13;10(5):e0127297. doi: 10.1371/journal.pone.0127297. eCollection 2015.
- Background: PubMed 20800544Said TM, Gaglani A, Agarwal A. Implication of apoptosis in sperm cryoinjury. Reprod Biomed Online. 2010 Oct;21(4):456-62. doi: 10.1016/j.rbmo.2010.05.011. Epub 2010 Jun 1.
- Background: PubMed 22541171Padilha RT, Magalhaes-Padilha DM, Cavalcante MM, Almeida AP, Haag KT, Gastal MO, Nunes JF, Rodrigues AP, Figueiredo JR, Oliveira MA. Effect of insulin-like growth factor-I on some quality traits and fertility of cryopreserved ovine semen. Theriogenology. 2012 Sep 1;78(4):907-13. doi: 10.1016/j.theriogenology.2012.04.005. Epub 2012 Apr 27.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm Cryodamage, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Sellés, PhD (+34 966012490 ext. 13503, elena.selles@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive sperm motility after thawing (time frame: Immediately after thawing of the semen samples.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07504575, which also lists 33 linked publications.
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 17 Apr 2026.