Effect of PRP in Donor Semen During Cryoprervation

Official title

Effect of Platelet-rich Plasma (PRP) on the Quality of Donor Semen During Cryopreservation

Overview

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.

Primary outcome measures

• Progressive sperm motility after thawing [Time frame: Immediately after thawing of the semen samples.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Spain · 1 center

• IVI Alicante — Alicante

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. PMID 17379653
• 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. PMID 30959025
• 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. PMID 33476642
• 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. PMID 19860937
• 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. PMID 11336487
• 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. PMID 29164757
• 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. PMID 30763565
• 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. PMID 27256665

Identifiers

NCT: NCT07504575 · 2503-ALC-038-ES

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗