- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07504575
Effect of PRP in Donor Semen During Cryoprervation (PRP)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Elena Sellés, PhD
- Phone Number: 13503 +34 966012490
- Email: elena.selles@ivirma.com
Study Locations
-
-
Alicante
-
Alicante, Alicante, Spain, 03015
- Recruiting
- IVI Alicante
-
Contact:
- Elena Sellés, PhD
- Phone Number: 13503 +34 966012490
- Email: elena.selles@ivirma.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age from 18 to 35 years
Concentration higher than 50 million progressively motile sperm.
Morphology: more than 4% normal sperm shapes.
Exclusion Criteria:
Presence of personal or hereditary pathology.
Presence of psychological or behavioral disorder.
Semen parameters below those indicated in the inclusion criteria.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
control
No PRP treatment
|
|
1%
1% PRP treatment
|
|
2%
2% PRP treatment
|
|
5%
5% PRP treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Immediately after thawing of the semen samples.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
- Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
- Blair P, Flaumenhaft R. Platelet alpha-granules: basic biology and clinical correlates. Blood Rev. 2009 Jul;23(4):177-89. doi: 10.1016/j.blre.2009.04.001. Epub 2009 May 17.
- McNicol 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.
- Seckin 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.
- 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.
- Yang 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.
- Yan 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.
- Verza 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.
- Sztein 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.
- Starmer 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.
- Shokri 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.
- Selvaraju 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.
- Saucedo 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.
- Said 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.
- Padilha 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.
- Nabavinia 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.
- Mirzaei 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.
- Li K, Rodriguez D, Gabrielsen JS, Centola GM, Tanrikut C. Sperm cryopreservation of transgender individuals: trends and findings in the past decade. Andrology. 2018 Nov;6(6):860-864. doi: 10.1111/andr.12527. Epub 2018 Aug 9.
- Karabulut S, Demiroglu-Zergeroglu A, Yilmaz E, Kutlu P, Keskin I. Effects of human sperm cryopreservation on apoptotic markers in normozoospermic and non-normozoospermic patients. Zygote. 2018 Aug;26(4):308-313. doi: 10.1017/S0967199418000254. Epub 2018 Sep 17.
- Iyibozkurt AC, Balcik P, Bulgurcuoglu S, Arslan BK, Attar R, Attar E. Effect of vascular endothelial growth factor on sperm motility and survival. Reprod Biomed Online. 2009 Dec;19(6):784-8. doi: 10.1016/j.rbmo.2009.09.019.
- Irmak G, Demirtas TT, Gumusderelioglu M. Sustained release of growth factors from photoactivated platelet rich plasma (PRP). Eur J Pharm Biopharm. 2020 Mar;148:67-76. doi: 10.1016/j.ejpb.2019.11.011. Epub 2019 Dec 5.
- Hezavehei M, Sharafi M, Kouchesfahani HM, Henkel R, Agarwal A, Esmaeili V, Shahverdi A. Sperm cryopreservation: A review on current molecular cryobiology and advanced approaches. Reprod Biomed Online. 2018 Sep;37(3):327-339. doi: 10.1016/j.rbmo.2018.05.012. Epub 2018 Aug 22.
- Gomez-Torres MJ, Medrano L, Romero A, Fernandez-Colom PJ, Aizpurua J. Effectiveness of human spermatozoa biomarkers as indicators of structural damage during cryopreservation. Cryobiology. 2017 Oct;78:90-94. doi: 10.1016/j.cryobiol.2017.06.008. Epub 2017 Jun 19.
- Ghasemian Nafchi H, Azizi Y, Amjadi F, Halvaei I. In vitro effects of plasma rich in growth factors on human teratozoospermic semen samples. Syst Biol Reprod Med. 2023 Aug;69(4):255-263. doi: 10.1080/19396368.2023.2180455. Epub 2023 Mar 15.
- El-Sherbiny HR, Abdelnaby EA, Samir H, Fathi M. Addition of autologous platelet rich plasma to semen extender enhances cryotolerance and fertilizing capacity of buffalo bull spermatozoa. Theriogenology. 2022 Dec;194:104-109. doi: 10.1016/j.theriogenology.2022.09.029. Epub 2022 Oct 4.
- Dogra Y, Singh N, Vanamail P. Autologous platelet-rich plasma optimizes endometrial thickness and pregnancy outcomes in women with refractory thin endometrium of varied aetiology during fresh and frozen-thawed embryo transfer cycles. JBRA Assist Reprod. 2022 Jan 17;26(1):13-21. doi: 10.5935/1518-0557.20210037.
- Dearing CG, Jayasena CN, Lindsay KS. Human sperm cryopreservation in cancer patients: Links with deprivation and mortality. Cryobiology. 2017 Dec;79:9-13. doi: 10.1016/j.cryobiol.2017.10.003. Epub 2017 Oct 12.
- Bader R, Ibrahim JN, Moussa M, Mourad A, Azoury J, Azoury J, Alaaeddine N. In vitro effect of autologous platelet-rich plasma on H2 O2 -induced oxidative stress in human spermatozoa. Andrology. 2020 Jan;8(1):191-200. doi: 10.1111/andr.12648. Epub 2019 May 12.
- Amidi F, Pazhohan A, Shabani Nashtaei M, Khodarahmian M, Nekoonam S. The role of antioxidants in sperm freezing: a review. Cell Tissue Bank. 2016 Dec;17(4):745-756. doi: 10.1007/s10561-016-9566-5. Epub 2016 Jun 24.
- Alonso-Frias P, Esbert M. Therapeutic use of platelet-rich plasma for the treatment of male infertility. Rev Int Androl. 2024 Sep;22(3):16-23. doi: 10.22514/j.androl.2024.018. Epub 2024 Sep 30.
- Almadaly EA, Ibrahim IM, Salama MS, Ashour MA, Sahwan FM, El-Kon II, Abouzed TK, El-Domany WB. Effect of platelet-rich plasma (PRP) on post-thaw quality, kinematics and in vivo fertility of fertile and subfertile buffalo (Bubalus bubalis) spermatozoa. Vet Res Commun. 2023 Jan;47(1):61-72. doi: 10.1007/s11259-022-09928-1. Epub 2022 Apr 22.
- Abdulla AK, Rebai T, Al-Delemi DHJ. Protective Effects of Autologous Platelet-Rich Plasma (PRP) on the Outcome of Cryopreservation in Rabbit Sperm. Cell Mol Biol (Noisy-le-grand). 2022 Apr 30;68(4):113-121. doi: 10.14715/cmb/2022.68.4.14.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2503-ALC-038-ES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sperm Cryodamage
-
CREA Medicina de la Reproducción SLRecruitingIntracytoplasmic Sperm Injection | Sperm | MicrofluidicsSpain
-
IVI MadridRecruitingSperm | Sperm DNA Fragmentation | Male Fertility | TelomeresSpain
-
Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity of BarcelonaCompleted
-
Instituto Valenciano de Infertilidad, IVI VALENCIAIVF 2.0 LimitedNot yet recruitingMale Fertility | Testicular | Sperm Parameters in Fertile and Infertile Men | Sperm Selection
-
Instituto Valenciano de Infertilidad, IVI VALENCIACompleted
-
UCB PharmaCompleted
-
Rajavithi HospitalRecruitingAutologous Platelet-rich Plasma Supplement | Sperm Cryopreservation | Post-cryopreserved Sperm Quality | Semen AnalysisThailand
-
BAIBYS FertilityActive, not recruiting
-
Assaf-Harofeh Medical CenterUnknownSperm CapacitationIsrael