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RecruitingNCT07504575

Effect of PRP in Donor Semen During Cryoprervation

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Instituto Valenciano de Infertilidad, IVI Alicante · Academic / Other
Sex
Male
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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 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.

Conditions

Timeline

Start date
2026-02-10
Primary completion
2027-09-30
Completion
2028-01-30
First posted
2026-04-01
Last updated
2026-04-17

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07504575. Inclusion in this directory is not an endorsement.