Human Sperm Cryopreservation as an Alternative to the Decline of Sperm Quality With Aging
8. September 2026 aktualisiert von: IVI Murcia
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.
Studienübersicht
Status
Rekrutierung
Detaillierte Beschreibung
The aging process is associated with declining fertility and increased risks of adverse reproductive and offspring health outcomes. Although the effects of maternal age have been extensively studied, the impact of paternal aging on sperm quality, reproductive outcomes, and molecular characteristics of sperm remains incompletely understood.
The primary objective of this study is to evaluate whether sperm cryopreservation may serve as an alternative to the use of sperm collected at older ages in assisted reproduction treatments. The primary endpoint is the difference in sperm DNA methylation patterns between fresh ejaculated samples and samples subjected to cryopreservation. Cryopreservation will be considered a potentially valid strategy if DNA methylation patterns remain substantially preserved following the cryopreservation process.
At least 45 male participants will be recruited and grouped according to age. Participants will provide one semen sample and a peripheral blood sample. Following routine semen analysis, each semen sample will be divided into three aliquots: fresh, slow-frozen, and vitrified. Cryopreserved aliquots will be stored in liquid nitrogen and subsequently thawed or warmed for analysis.
Standard semen parameters, including volume, concentration, motility, sperm kinetics, and morphology, will be evaluated. Additional analyses will include sperm DNA methylation, DNA fragmentation, telomere length, and characterization of extracellular vesicles and their composition. Identical assessments will be performed on fresh and cryopreserved samples to compare the effects of slow freezing and vitrification.
Secondary objectives include evaluating age-related differences in semen quality and molecular biomarkers, identifying markers associated with biological gamete age, characterizing age-related differences in seminal extracellular vesicles, and exploring associations between sperm molecular characteristics and lifestyle. Participants will also complete validated questionnaires regarding lifestyle and dietary habits.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
45
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Murcia
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Murcia, Murcia, Spanien, 30007
- Rekrutierung
- IVI Murcia
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Kontakt:
- Juan Carlos Martínez
- Telefonnummer: +34 651 79 10 00
- E-Mail: JuanCarlos.Martinez@ivirma.com
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Presence of varicocele
- Current use of vitamin or antioxidant supplements intended to improve semen quality
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Men aged 18-39 years
Male participants aged 18-39 years who provide semen and blood samples for laboratory assessment of sperm quality and molecular characteristics.
Semen samples are divided into fresh, slow-frozen, and vitrified aliquots for comparative analysis.
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Men aged 40-49 years
Male participants aged 40-49 years who provide semen and blood samples for laboratory assessment of sperm quality and molecular characteristics.
Semen samples are divided into fresh, slow-frozen, and vitrified aliquots for comparative analysis.
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Men aged ≥50 years
Male participants aged 50 years and older who provide semen and blood samples for laboratory assessment of sperm quality and molecular characteristics.
Semen samples are divided into fresh, slow-frozen, and vitrified aliquots for comparative analysis.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sperm DNA methylation profile
Zeitfenster: Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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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.
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Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sperm concentration
Zeitfenster: Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Sperm concentration (million sperm/mL) measured using computer-assisted sperm analysis (CASA).
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Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Total sperm motility
Zeitfenster: Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Percentage of motile sperm measured using CASA.
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Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Progressive sperm motility
Zeitfenster: Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Percentage of progressively motile sperm measured using computer-assisted sperm analysis (CASA).
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Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Normal sperm morphology
Zeitfenster: Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Percentage of sperm with normal morphology assessed by microscopic evaluation of stained slides according to World Health Organization (WHO) criteria.
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Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Sperm DNA fragmentation
Zeitfenster: Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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DNA fragmentation measured in fresh, slow-frozen, and vitrified sperm samples.
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Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Sperm telomere length
Zeitfenster: Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Sperm telomere length measured in fresh, slow-frozen, and vitrified sperm samples.
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Baseline (study semen collection visit) and after thawing of cryopreserved semen samples, through study completion (up to 9 months).
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Seminal plasma extracellular vesicle composition
Zeitfenster: Baseline (study semen collection visit).
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Characterization of seminal plasma extracellular vesicle composition in fresh semen samples.
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Baseline (study semen collection visit).
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Blood leukocyte telomere length
Zeitfenster: Baseline (study blood collection visit).
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Blood cell telomere length measured to investigate its relationship with participant age and sperm molecular characteristics.
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Baseline (study blood collection visit).
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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- Practice Committee of the American Society for Reproductive Medicine. The clinical utility of sperm DNA integrity testing: a guideline. Fertil Steril. 2013 Mar 1;99(3):673-7. doi: 10.1016/j.fertnstert.2012.12.049. Epub 2013 Feb 1.
- Njajou OT, Cawthon RM, Damcott CM, Wu SH, Ott S, Garant MJ, Blackburn EH, Mitchell BD, Shuldiner AR, Hsueh WC. Telomere length is paternally inherited and is associated with parental lifespan. Proc Natl Acad Sci U S A. 2007 Jul 17;104(29):12135-9. doi: 10.1073/pnas.0702703104. Epub 2007 Jul 10.
- Machtinger R, Laurent LC, Baccarelli AA. Extracellular vesicles: roles in gamete maturation, fertilization and embryo implantation. Hum Reprod Update. 2016 Mar-Apr;22(2):182-93. doi: 10.1093/humupd/dmv055. Epub 2015 Dec 9.
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- Kumar P, Wang M, Isachenko E, Rahimi G, Mallmann P, Wang W, von Brandenstein M, Isachenko V. Unraveling Subcellular and Ultrastructural Changes During Vitrification of Human Spermatozoa: Effect of a Mitochondria-Targeted Antioxidant and a Permeable Cryoprotectant. Front Cell Dev Biol. 2021 Jul 2;9:672862. doi: 10.3389/fcell.2021.672862. eCollection 2021.
- Klaver R, Bleiziffer A, Redmann K, Mallidis C, Kliesch S, Gromoll J. Routine cryopreservation of spermatozoa is safe--evidence from the DNA methylation pattern of nine spermatozoa genes. J Assist Reprod Genet. 2012 Sep;29(9):943-50. doi: 10.1007/s10815-012-9813-z. Epub 2012 Jun 13.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
10. Juni 2026
Primärer Abschluss (Geschätzt)
31. März 2027
Studienabschluss (Geschätzt)
30. September 2027
Studienanmeldedaten
Zuerst eingereicht
29. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. September 2026
Zuerst gepostet (Tatsächlich)
10. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2303-MUR-046-JM
- 101120126 (Andere Zuschuss-/Finanzierungsnummer: European Union Horizon Europe Programme - Marie Skłodowska-Curie Actions Doctoral Network AFRODITA)
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