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.
Sponsor:
Information provided by:
Biocoat
ClinicalTrials.gov Identifier:
NCT00741494
First received: August 25, 2008
Last updated: December 26, 2010
Last verified: December 2010
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741494

Locations
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
Reproductive Biology Associates
Atlanta, Georgia, United States, 30342
Georgia Reproductive Specialists
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
Biocoat
Investigators
Study Director: Kathryn Worrilow, Ph.D. Biocoat
  More Information

No publications provided by Biocoat

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathryn Worrilow, Biocoat, Inc.
ClinicalTrials.gov Identifier: NCT00741494     History of Changes
Other Study ID Numbers: 2008PICSI03
Study First Received: August 25, 2008
Last Updated: December 26, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014