Sperm Selection Strategies and Male-Factor Phenotypes in ICSI

NCT07825584 | Active Not Recruiting

• 1 other identifier: ANDRO-ART-01
• Study Type: observational
• Target: 12,561
• Locations: 1 country
• Sites: 10

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.

Conditions

Assisted Reproductive Technology; Assisted Reproductive Technology Outcomes

Keywords

Intracytoplasmic Sperm Injection; ICSI; PICSI; Hyaluronan-Binding Sperm Selection; Microfluidic Sperm Selection; ZyMōt; Sperm DNA Fragmentation; SDF; Male Factor Infertility; Pregnancy Loss; Miscarriage

Outcome Measures

Primary Outcomes (1)

• 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%.

  Up to 22 completed weeks of gestation

Secondary Outcomes (4)

• Clinical Pregnancy

  Up to 8 weeks after embryo transfer

• 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

• Normal Fertilization Rate

  Approximately 16-18 hours after ICSI

• Blastocyst Development Rate

  From normal fertilization assessment through day 5-7 of embryo culture

Other Outcomes (2)

• No Usable Embryo per Initiated ICSI Cycle

  From ICSI through completion of embryo culture for the source cycle

• Zero 2PN per Initiated ICSI Cycle

  Approximately 16-18 hours after ICSI

Study Arms (3)

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

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

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

Interventions

Conventional ICSI PROCEDURE

Intracytoplasmic sperm injection performed after routine conventional sperm preparation without hyaluronan-binding sperm selection or microfluidic sperm selection.

Conventional ICSI

Hyaluronan-Binding Sperm Selection PROCEDURE

Hyaluronan-binding sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.

PICSI

ZyMōt PROCEDURE

Microfluidic sperm selection used before intracytoplasmic sperm injection as part of routine clinical practice.

Microfluidic Sperm Selection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Reproductive Medicine Bocian: lead

Study Sites (10)

Bocian Fertility Clinic, Poznań

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

Bocian Fertility Clinic, Lublin

Lublin, Lublin Voivodeship, 20-819, Poland

Location

Bocian Fertility Clinic, Warsaw Śródmieście

Warsaw, Masovian Voivodeship, 00-193, Poland

Location

Bocian Fertility Clinic, Rzeszów

Rzeszów, Podkarpackie Voivodeship, 35-309, Poland

Location

Bocian Fertility Clinic, Białystok

Bialystok, Podlaskie Voivodeship, 15-267, Poland

Location

Bocian Fertility Clinic, Gdańsk

Gdansk, Pomeranian Voivodeship, 80-244, Poland

Location

Bocian Fertility Clinic, Katowice

Katowice, Silesian Voivodeship, 40-081, Poland

Location

Bocian Fertility Clinic, Szczecin

Szczecin, West Pomeranian Voivodeship, 70-225, Poland

Location

Bocian Fertility Clinic, Łódź

Lodz, Łódź Voivodeship, 90-440, Poland

Location

Bocian Fertility Clinic, Kielce

Kielce, Świętokrzyskie Voivodeship, 25-435, Poland

Location

Related Publications (3)

• 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.

  PMID: 37983267 RESULT

• 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.

  PMID: 40723352 RESULT

• 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/

  PMID: 30758931 RESULT

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Przemysław Ciepiela, MD, PhD

  Bocian Fertility Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 17, 2026
• Study Start: January 2, 2020
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (10)