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Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)

This study has been completed.
Information provided by:
Biocoat Identifier:
First received: August 25, 2008
Last updated: December 26, 2010
Last verified: December 2010
The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA).

Condition Intervention
Male Factor Infertility
Device: PICSI dish

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI) for Patients Having a Low Versus High Proportion of Hyaluronan Binding Sperm (HBA)

Resource links provided by NLM:

Further study details as provided by Biocoat:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 8 weeks post ICSI ]

Enrollment: 801
Study Start Date: August 2008
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
HBA score over 65% control
No Intervention: 2
HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)
Active Comparator: 3
HBA score over 65%. PICSI dish is used to select the sperm for ICSI.
Device: PICSI dish
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
Experimental: 4
HBA score less than 65%. PICSI dish used to select sperm for ICSI.
Device: PICSI dish
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
No Intervention: 5
HBA Score less than 65%. Control


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • IVF patients who require the ICSI procedure and whose care is being managed by the clinical and scientific staff of the participating groups, will be included in the study.

Exclusion Criteria:

  • IVF patients who do not require the ICSI procedure will be excluded from the study. In addition the following groups of patients will also be excluded:

    • Patients using testicular sperm.
    • Patients using donor sperm.
    • Patients where the female partner is over 40 years of age
    • Patients who have an initial HBA score less than or equal to 2%
    • Patients who have a sperm count less than or equal to 10,000 motile sperm per ml.
    • Patients who produce less than 4 Metaphase II oocytes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00741494

United States, California
Huntington Reproductive Center
Laguna Hills, California, United States, 92653
Reproductive Science Center of the Bay Area
San Ramon, California, United States, 94583
United States, Georgia
Georgia Reproductive Specialists
Atlanta, Georgia, United States, 30342
Reproductive Biology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Fertility Centers of Illinois
Chicago, Illinois, United States, 60610
United States, New York
CNY Fertility Center
Syracuse, New York, United States, 13205
United States, Pennsylvania
Abington IVF and Genetics Toll Center for Reprodcution
Abington, Pennsylvania, United States, 19001
United States, Rhode Island
Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02903
United States, Washington
Seattle Reproductive Medicine
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Study Director: Kathryn Worrilow, Ph.D. Biocoat
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kathryn Worrilow, Biocoat, Inc. Identifier: NCT00741494     History of Changes
Other Study ID Numbers: 2008PICSI03
Study First Received: August 25, 2008
Last Updated: December 26, 2010

Keywords provided by Biocoat:
hyaluronan binding
sperm selection
male factor
sperm maturity
clinical pregnancy rates
hyaluronan binding assay

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on May 25, 2017