Sperm Selection Strategies and Male-Factor Phenotypes in ICSI (ANDRO-ART)
2026年9月11日 更新者：Center for Reproductive Medicine Bocian
Comparative Effectiveness of Conventional ICSI, Hyaluronan-Binding Sperm Selection, and Microfluidic Sperm Selection Across Male-Factor Phenotypes: A Multicentre Retrospective Cohort Study
This retrospective multicentre observational cohort study evaluates clinical and reproductive outcomes associated with different sperm-selection strategies used during intracytoplasmic sperm injection (ICSI), including conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
The study uses routinely collected real-world clinical and laboratory data from fertility treatment cycles performed at multiple centres.
Analyses will assess overall comparative effectiveness and whether treatment effects differ according to male-factor phenotypes, including sperm DNA fragmentation.
Key outcomes include fertilization, embryo development, pregnancy establishment, pregnancy loss, and cumulative reproductive outcomes at the source-cycle level.
The study is observational; treatment allocation was determined by routine clinical practice rather than by a study protocol.
調査の概要
状態
積極的、募集していない
詳細な説明
The ANDRO-ART study is a retrospective, multicentre, observational cohort study based on routinely collected clinical and embryological data from ICSI treatment cycles performed across multiple fertility centres. The study compares three sperm-selection strategies used in routine clinical practice: conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
The primary analytical framework will evaluate comparative effectiveness in the overall cohort, followed by prespecified phenotype-specific analyses. Particular attention will be given to male-factor biomarkers, including sperm DNA fragmentation, in order to assess whether the clinical association between sperm-selection strategy and reproductive outcomes differs across biologically defined subgroups.
Outcomes of interest include fertilization, embryo development, clinical pregnancy, pregnancy loss, and cumulative reproductive outcomes evaluated from the source ICSI cycle. Additional analyses may include treatment-by-phenotype interactions, subgroup analyses based on sperm DNA fragmentation categories, and sensitivity analyses designed to address confounding and centre-level heterogeneity.
The study is non-interventional. Patients were not assigned to sperm-selection strategies according to a research protocol; all procedures were performed as part of routine fertility treatment. Historical data will be analysed using predefined eligibility criteria and statistical methods before final data freeze.
研究の種類
観察的
入学 (推定)
12561
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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Greater Poland Voivodeship
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Poznan、Greater Poland Voivodeship、ポーランド、60-529
- Bocian Fertility Clinic, Poznań
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Lublin Voivodeship
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Lublin、Lublin Voivodeship、ポーランド、20-819
- Bocian Fertility Clinic, Lublin
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Masovian Voivodeship
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Warsaw、Masovian Voivodeship、ポーランド、00-193
- Bocian Fertility Clinic, Warsaw Śródmieście
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Podkarpackie Voivodeship
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Rzeszów、Podkarpackie Voivodeship、ポーランド、35-309
- Bocian Fertility Clinic, Rzeszów
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Podlaskie Voivodeship
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Bialystok、Podlaskie Voivodeship、ポーランド、15-267
- Bocian Fertility Clinic, Białystok
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Pomeranian Voivodeship
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Gdansk、Pomeranian Voivodeship、ポーランド、80-244
- Bocian Fertility Clinic, Gdańsk
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Silesian Voivodeship
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Katowice、Silesian Voivodeship、ポーランド、40-081
- Bocian Fertility Clinic, Katowice
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West Pomeranian Voivodeship
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Szczecin、West Pomeranian Voivodeship、ポーランド、70-225
- Bocian Fertility Clinic, Szczecin
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Łódź Voivodeship
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Lodz、Łódź Voivodeship、ポーランド、90-440
- Bocian Fertility Clinic, Łódź
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Świętokrzyskie Voivodeship
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Kielce、Świętokrzyskie Voivodeship、ポーランド、25-435
- Bocian Fertility Clinic, Kielce
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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
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The study population comprises adult women undergoing ICSI treatment in routine clinical practice across multiple fertility centres.
Eligible source ICSI cycles are retrospectively classified according to the sperm-selection strategy used: conventional ICSI, hyaluronan-binding sperm selection (PICSI), or microfluidic sperm selection.
The primary analysis includes an unselected all-comers population, with prespecified phenotype-specific analyses according to male-factor characteristics, including sperm DNA fragmentation.
説明
Inclusion Criteria:
- Adult women undergoing an ICSI source cycle at a participating fertility centre during the study period.
- Source cycles performed using conventional ICSI, hyaluronan-binding sperm selection (PICSI), or microfluidic sperm selection.
- Availability of routinely collected clinical and embryological data sufficient to classify the sperm-selection strategy and evaluate at least one prespecified study outcome.
Exclusion Criteria:
- Cycles not involving ICSI.
- Records with insufficient or internally inconsistent data preventing reliable identification of the source ICSI cycle or sperm-selection strategy.
- Cycles involving combined hyaluronan-binding and microfluidic sperm selection are excluded from the primary three-group comparative analysis and may be evaluated separately in prespecified sensitivity analyses.
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 |
介入・治療 |
|---|---|
|
Conventional ICSI
ICSI source cycles in which spermatozoa were selected using routine conventional laboratory preparation without hyaluronan-binding or microfluidic sperm selection.
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Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.
|
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PICSI
ICSI source cycles in which spermatozoa were selected using hyaluronan-binding sperm selection (PICSI) as part of routine clinical practice.
|
Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
|
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Microfluidic Sperm Selection
ICSI source cycles in which spermatozoa were prepared using a microfluidic sperm-selection device (ZyMōt) as part of routine clinical practice.
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Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
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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 |
|---|---|---|
|
Pregnancy Loss After Clinical Pregnancy
時間枠：Up to 22 completed weeks of gestation
|
Pregnancy loss following an established clinical pregnancy.
The proportion of clinical pregnancies resulting in pregnancy loss will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
Prespecified analyses will assess effect modification by sperm DNA fragmentation, including SDF >20% versus ≤20%.
|
Up to 22 completed weeks of gestation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Pregnancy
時間枠：Up to 8 weeks after embryo transfer
|
Clinical pregnancy following embryo transfer, assessed according to routinely recorded clinical follow-up.
The proportion of embryo transfers resulting in clinical pregnancy will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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Up to 8 weeks after embryo transfer
|
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Cumulative Clinical Pregnancy per Source ICSI Cycle
時間枠：From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
|
Occurrence of at least one clinical pregnancy resulting from fresh and/or frozen-thawed embryo transfers derived from the same source ICSI cycle.
The cumulative proportion of source ICSI cycles resulting in at least one clinical pregnancy will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
|
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Normal Fertilization Rate
時間枠：Approximately 16-18 hours after ICSI
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Proportion of mature oocytes (MII) undergoing ICSI that demonstrated normal fertilization, defined by the presence of two pronuclei (2PN).
Normal fertilization rate will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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Approximately 16-18 hours after ICSI
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Blastocyst Development Rate
時間枠：From normal fertilization assessment through day 5-7 of embryo culture
|
Proportion of normally fertilized oocytes (2PN) developing to the blastocyst stage.
Blastocyst development rate will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
|
From normal fertilization assessment through day 5-7 of embryo culture
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
No Usable Embryo per Initiated ICSI Cycle
時間枠：From ICSI through completion of embryo culture for the source cycle
|
Proportion of initiated ICSI source cycles resulting in no embryo considered usable for transfer and/or cryopreservation according to routine laboratory assessment.
The outcome is defined at the source-cycle level as zero usable embryos and will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
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From ICSI through completion of embryo culture for the source cycle
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Zero 2PN per Initiated ICSI Cycle
時間枠：Approximately 16-18 hours after ICSI
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Proportion of initiated ICSI source cycles in which no normally fertilized oocyte (2PN) was observed after ICSI.
This outcome will be compared across conventional ICSI, hyaluronan-binding sperm selection (PICSI), and microfluidic sperm selection.
|
Approximately 16-18 hours after ICSI
|
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。
捜査官
- 主任研究者：Przemysław Ciepiela, MD, PhD、Bocian Fertility Clinic
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
- Ferreira Aderaldo J, da Silva Maranhao K, Ferreira Lanza DC. Does microfluidic sperm selection improve clinical pregnancy and miscarriage outcomes in assisted reproductive treatments? A systematic review and meta-analysis. PLoS One. 2023 Nov 20;18(11):e0292891. doi: 10.1371/journal.pone.0292891. eCollection 2023.
- Gisbert Iranzo A, Cano-Extremera M, Hervas I, Falquet Guillem M, Gil Julia M, Navarro-Gomezlechon A, Pacheco-Rendon RM, Garrido N. Sperm Selection Using Microfluidic Techniques Significantly Decreases Sperm DNA Fragmentation (SDF), Enhancing Reproductive Outcomes: A Systematic Review and Meta-Analysis. Biology (Basel). 2025 Jun 30;14(7):792. doi: 10.3390/biology14070792.
- Kirkman-Brown J, Pavitt S, Khalaf Y, Lewis S, Hooper R, Bhattacharya S, Coomarasamy A, Sharma V, Brison D, Forbes G, West R, Pacey A, Brian K, Cutting R, Bolton V, Miller D. Sperm selection for assisted reproduction by prior hyaluronan binding: the HABSelect RCT. Southampton (UK): NIHR Journals Library; 2019 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK537400/
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)
2020年1月2日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年9月6日
QC基準を満たした最初の提出物
2026年9月11日
最初の投稿 (実際)
2026年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17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11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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ANDRO-ART-01
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?
いいえ
IPD プランの説明
Individual participant data will not be shared because the study is based on retrospectively collected multicentre clinical data containing sensitive health information.
Data sharing is additionally subject to institutional governance, data-protection regulations, and restrictions related to the original clinical databases.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。