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Clinical Trials/NCT07504575
NCT07504575
Recruiting
Not Applicable

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

Instituto Valenciano de Infertilidad, IVI Alicante1 site in 1 country20 target enrollmentStarted: February 10, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Instituto Valenciano de Infertilidad, IVI Alicante
Enrollment
20
Locations
1
Primary Endpoint
Progressive sperm motility after thawing

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

control

No PRP treatment

1%

1% PRP treatment

2%

2% PRP treatment

5%

5% PRP treatment

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto Valenciano de Infertilidad, IVI Alicante
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elena Sellés Soriano

Principal Investigator

Instituto Valenciano de Infertilidad, IVI Alicante

Study Sites (1)

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