Human Sperm Cryopreservation as an Alternative to the Decline of Sperm Quality With Aging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-65
SponsorIVI Murcia
About this trial
This observational study will evaluate whether sperm cryopreservation can help preserve sperm quality and molecular characteristics that may be affected by increasing paternal age. Men aged 18 years and older will provide a semen sample and a blood sample for laboratory analysis. Each semen sample will be divided into fresh, slow-frozen, and vitrified aliquots. The study will compare sperm quality (as assessed by computer-assisted sperm analysis), DNA methylation profiles, DNA fragmentation, sperm telomere length before and after cryopreservation. The effects of age on these parameters will also be assessed. The impact of age on seminal plasma extracellular vesicle composition and blood cell telomere length will also be analysed. The goal is to determine whether sperm cryopreservation may represent a strategy for preserving sperm characteristics associated with younger paternal age.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male participants aged 18 to 65 years
Attending IVI Murcia for semen analysis and/or assisted reproduction treatment
Able and willing to provide written informed consent
Willing to provide a semen sample and a blood sample for research purposes
Disqualifiers
Previous diagnosis of azoospermia or severe oligozoospermia (sperm concentration <1 million sperm/mL)
Known chromosomal abnormality (abnormal karyotype)
Known Y chromosome microdeletion
Febrile illness within the previous 3 months
Trial population
Adult men aged 18-65 years attending IVI Murcia for semen analysis, fertility assessment, semen donation, or assisted reproduction treatment who meet the study eligibility criteria and provide informed consent. Participants will provide semen and blood samples for laboratory assessment of sperm quality and molecular characteristics before and after cryopreservation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 3 trial groupsGroup A: Men aged 18-39 years
Group B: Men aged 40-49 years
Group C: Men aged ≥50 years
Trial outcomes
Primary outcomes
1
Sperm DNA methylation profile
DNA methylation levels of a predefined nine-gene panel measured by pyrosequencing with duplicate measurements and compared between fresh, slow-frozen, and vitrified sperm samples.
Time frame
Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).Secondary outcomes
1
Sperm concentration
Sperm concentration (million sperm/mL) measured using computer-assisted sperm analysis (CASA).
Time frame
Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).2
Total sperm motility
Percentage of motile sperm measured using CASA.
Time frame
Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).3
Progressive sperm motility
Percentage of progressively motile sperm measured using computer-assisted sperm analysis (CASA).
Time frame
Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).4
Normal sperm morphology
Percentage of sperm with normal morphology assessed by microscopic evaluation of stained slides according to World Health Organization (WHO) criteria.
Time frame
Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).Other outcomes
1
Blood leukocyte telomere length
Blood cell telomere length measured to investigate its relationship with participant age and sperm molecular characteristics.
Time frame
Baseline (study blood collection visit).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IVI Murcia
Lead sponsor
European Union
Collaborator
Source ClinicalTrials.gov