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

December 26, 2010 updated by: Biocoat

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

801

Phase

  • Not Applicable

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

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

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

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 8 weeks post ICSI
8 weeks post ICSI

Collaborators and Investigators

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

Sponsor

Biocoat

Investigators

  • Study Director: Kathryn Worrilow, Ph.D., Biocoat

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

August 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 28, 2010

Last Update Submitted That Met QC Criteria

December 26, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008PICSI03

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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