An observational study in Assisted Reproductive Technology and Assisted Reproductive Technology Outcomes, sponsored by Center for Reproductive Medicine Bocian. Active, not recruiting at 10 sites in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Center for Reproductive Medicine Bocian · Observational
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.
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.
221 studies on the registry are indexed under Abortion, Spontaneous; 44 are open to participants now.
This study's planned enrollment of 12,561 is above the median of 201 across 98 observational studies indexed under Abortion, Spontaneous.
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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.
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Exclusion Criteria:
ICSI source cycles in which spermatozoa were selected using routine conventional laboratory preparation without hyaluronan-binding or microfluidic sperm selection.
Procedure: Conventional ICSI
ICSI source cycles in which spermatozoa were selected using hyaluronan-binding sperm selection (PICSI) as part of routine clinical practice.
Procedure: Hyaluronan-Binding Sperm Selection
ICSI source cycles in which spermatozoa were prepared using a microfluidic sperm-selection device (ZyMōt) as part of routine clinical practice.
Procedure: ZyMōt
Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.
Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
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%.
Time frame: Up to 22 completed weeks of gestation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From normal fertilization assessment through day 5-7 of embryo culture
No Usable Embryo per Initiated ICSI 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.
Time frame: From ICSI through completion of embryo culture for the source cycle
Zero 2PN per Initiated ICSI Cycle
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.
Time frame: Approximately 16-18 hours after ICSI
Plan to share: 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.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Center for Reproductive Medicine Bocian