Assisted Reproductive Technology, Assisted Reproductive Technology Outcomes
Conditions
Keywords
Intracytoplasmic Sperm Injection, ICSI, PICSI, Hyaluronan-Binding Sperm Selection, Microfluidic Sperm Selection, ZyMōt, Sperm DNA Fragmentation, SDF, Male Factor Infertility, Pregnancy Loss, Miscarriage
Brief 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. 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.
Interventions
PROCEDUREConventional ICSI
Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.
PROCEDUREHyaluronan-Binding Sperm Selection
Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
PROCEDUREZyMōt
Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
Sponsors
Center for Reproductive Medicine Bocian
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Loss After Clinical Pregnancy | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy | 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. |
| Cumulative Clinical Pregnancy per Source ICSI Cycle | 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. |
| Normal Fertilization Rate | Approximately 16-18 hours after ICSI | 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. |
| Blastocyst Development Rate | 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. |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORPrzemysław Ciepiela, MD, PhD
Bocian Fertility Clinic
Outcome results
None listed