Assisted Reproductive TechnologyANDRO-ARTNCT07825584
Sperm Selection Strategies and Male-Factor Phenotypes in ICSI
An observational study of Assisted Reproductive Technology and Assisted Reproductive Technology Outcomes, run by Center for Reproductive Medicine Bocian at 10 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Assisted Reproductive Technology, Assisted Reproductive Technology Outcomes
- What is being tested?
- Conventional ICSI, Hyaluronan-Binding Sperm Selection and ZyMōt
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 12,561 participants
- Where
- 10 sitesPoland
- Study dates
- 2 Jan 2020to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Poland10 sites
Bocian Fertility Clinic, Białystok
Bialystok, Podlaskie Voivodeship, 15-267
Bocian Fertility Clinic, Gdańsk
Gdansk, Pomeranian Voivodeship, 80-244
Bocian Fertility Clinic, Katowice
Katowice, Silesian Voivodeship, 40-081
Bocian Fertility Clinic, Kielce
Kielce, Świętokrzyskie Voivodeship, 25-435
Bocian Fertility Clinic, Łódź
Lodz, Łódź Voivodeship, 90-440
Bocian Fertility Clinic, Lublin
Lublin, Lublin Voivodeship, 20-819
Bocian Fertility Clinic, Poznań
Poznan, Greater Poland Voivodeship, 60-529
Bocian Fertility Clinic, Rzeszów
Rzeszów, Podkarpackie Voivodeship, 35-309
Bocian Fertility Clinic, Szczecin
Szczecin, West Pomeranian Voivodeship, 70-225
Bocian Fertility Clinic, Warsaw Śródmieście
Warsaw, Masovian Voivodeship, 00-193
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Conventional ICSI, Hyaluronan-Binding Sperm Selection, ZyMōt
- Keywords
- Intracytoplasmic Sperm Injection, ICSI, PICSI, Hyaluronan-Binding Sperm Selection, Microfluidic Sperm Selection, ZyMōt, Sperm DNA Fragmentation, SDF, Male Factor Infertility, Pregnancy Loss, Miscarriage
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional ICSIProcedure or surgery
Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.
Hyaluronan-Binding Sperm SelectionProcedure or surgery
Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
ZyMōtProcedure or surgery
Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ICSI | ICSI source cycles in which spermatozoa were selected using routine conventional laboratory preparation without hyaluronan-binding or microfluidic sperm selection. Receives: Procedure: Conventional ICSI | |
| PICSI | ICSI source cycles in which spermatozoa were selected using hyaluronan-binding sperm selection (PICSI) as part of routine clinical practice. Receives: Procedure: Hyaluronan-Binding Sperm Selection | |
| Microfluidic Sperm Selection | ICSI source cycles in which spermatozoa were prepared using a microfluidic sperm-selection device (ZyMōt) as part of routine clinical practice. Receives: Procedure: ZyMōt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Loss After Clinical Pregnancy
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%.
Measured: Up to 22 completed weeks of gestation
Secondary outcomes (4)
Clinical Pregnancy
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.
Measured: Up to 8 weeks after embryo transfer
Cumulative Clinical Pregnancy per Source ICSI Cycle
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.
Measured: From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
Normal Fertilization Rate
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.
Measured: Approximately 16-18 hours after ICSI
Blastocyst Development Rate
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.
Measured: From normal fertilization assessment through day 5-7 of embryo culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start2 Jan 2020
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,561 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Reproductive Medicine Bocian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Przemysław Ciepiela, MD, PhD, Principal investigator, Bocian Fertility Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825584
- Sponsor's protocol ID
- ANDRO-ART-01
- Acronym
- ANDRO-ART
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37983267Gisbert 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.
PubMed 40723352Kirkman-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/
PubMed 30758931
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Conventional ICSI, Hyaluronan-Binding Sperm Selection, and Microfluidic Sperm Selection Across Male-Factor Phenotypes: A Multicentre Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07825584
- Acronym / sponsor ID
- ANDRO-ART / ANDRO-ART-01
- Keywords
- Intracytoplasmic Sperm Injection, ICSI, PICSI, Hyaluronan-Binding Sperm Selection, Microfluidic Sperm Selection, ZyMōt, Sperm DNA Fragmentation, SDF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,561 participants (estimated)
- Lead sponsor
- Center for Reproductive Medicine BocianUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional ICSI | – | Procedure: Conventional ICSIICSI source cycles in which spermatozoa were selected using routine conventional laboratory preparation without hyaluronan-binding or microfluidic sperm selection. |
| PICSI | – | Procedure: Hyaluronan-Binding Sperm SelectionICSI source cycles in which spermatozoa were selected using hyaluronan-binding sperm selection (PICSI) as part of routine clinical practice. |
| Microfluidic Sperm Selection | – | Procedure: ZyMōtICSI source cycles in which spermatozoa were prepared using a microfluidic sperm-selection device (ZyMōt) as part of routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional ICSIIntracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection. | Procedure or surgery | Conventional ICSI |
| Hyaluronan-Binding Sperm SelectionHyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice. | Procedure or surgery | PICSI |
| ZyMōtMicrofluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice. | Procedure or surgery | Microfluidic Sperm Selection |
Primary outcome
Pregnancy Loss After Clinical Pregnancy
Time frame: 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%.
4 secondary outcomes
Clinical Pregnancy
Time frame: Up to 8 weeks after embryo transfer
Cumulative Clinical Pregnancy per Source ICSI Cycle
Time frame: From the source ICSI procedure through the last recorded embryo transfer derived from that procedure, up to 5 years
Normal Fertilization Rate
Time frame: Approximately 16-18 hours after ICSI
Blastocyst Development Rate
Time frame: From normal fertilization assessment through day 5-7 of embryo culture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publication: PubMed 37983267Ferreira 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.
- Results publication: PubMed 40723352Gisbert 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.
- Results publication: PubMed 30758931Kirkman-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/
- Individual participant dataSharing planned: No. 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.
Related trials for Assisted Reproductive Technology
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Enrolling by invitation
Investigation of the Treatment of Patients With Mitochondrial Defects by Assisted Reproductive Technology
Pearson Syndrome, Mitochondria DNA Deletion
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Not yet recruitingObservational study
Low TGF-β and Embryo Implantation in the Context of Assisted Reproductive Technology: Confirmation of a Biomarker Predictive of Success and Characterization of the Immune Microenvironment.
Infertility, Female, Pregnancy Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Przemysław Ciepiela, MD, PhD principal investigator
Bocian Fertility Clinic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assisted Reproductive Technology and Assisted Reproductive Technology Outcomes, run by Center for Reproductive Medicine Bocian at 10 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Loss After Clinical Pregnancy (time frame: Up to 22 completed weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07825584, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.