Sperm Selection Strategies and Male-Factor Phenotypes in ICSI (ANDRO-ART)

September 11, 2026 updated by: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

12561

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-529
        • Bocian Fertility Clinic, Poznań
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-819
        • Bocian Fertility Clinic, Lublin
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-193
        • Bocian Fertility Clinic, Warsaw Śródmieście
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-309
        • Bocian Fertility Clinic, Rzeszów
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-267
        • Bocian Fertility Clinic, Białystok
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-244
        • Bocian Fertility Clinic, Gdańsk
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-081
        • Bocian Fertility Clinic, Katowice
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-225
        • Bocian Fertility Clinic, Szczecin
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-440
        • Bocian Fertility Clinic, Łódź
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-435
        • Bocian Fertility Clinic, Kielce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conventional ICSI
ICSI source cycles in which spermatozoa were selected using routine conventional laboratory preparation without hyaluronan-binding or microfluidic sperm selection.
Procedure: Conventional ICSI
Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.
PICSI
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
Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.
Microfluidic 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
Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Up to 22 completed weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy
Time Frame: 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.
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
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.
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
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.
Approximately 16-18 hours after ICSI
Blastocyst Development Rate
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
No Usable Embryo per Initiated ICSI Cycle
Time Frame: 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.
From ICSI through completion of embryo culture for the source cycle
Zero 2PN per Initiated ICSI Cycle
Time Frame: Approximately 16-18 hours after ICSI
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Reproductive Medicine Bocian

Investigators

  • Principal Investigator: Przemysław Ciepiela, MD, PhD, Bocian Fertility Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANDRO-ART-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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