Human Sperm Cryopreservation as an Alternative to the Decline of Sperm Quality With Aging
2026年9月8日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
観察的
入学 (推定)
45
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Murcia
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Murcia、Murcia、スペイン、30007
- 募集
- IVI Murcia
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コンタクト：
- Juan Carlos Martínez
- 電話番号：+34 651 79 10 00
- メール：JuanCarlos.Martinez@ivirma.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sperm DNA methylation profile
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sperm concentration
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood leukocyte telomere length
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月10日
一次修了 (推定)
2027年3月31日
研究の完了 (推定)
2027年9月30日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
2026年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2303-MUR-046-JM
- 101120126 (その他の助成金/資金番号：European Union Horizon Europe Programme - Marie Skłodowska-Curie Actions Doctoral Network AFRODITA)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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