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

Primary Purpose

Male Factor Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PICSI dish
Sponsored by
Biocoat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Factor Infertility focused on measuring infertility, ICSI, hyaluronan binding, sperm, sperm selection, male factor, hyaluronan, sperm maturity, clinical pregnancy rates, hyaluronan binding assay, HBA, PICSI

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huntington Reproductive Center
  • Reproductive Science Center of the Bay Area
  • Georgia Reproductive Specialists
  • Reproductive Biology Associates
  • Fertility Centers of Illinois
  • CNY Fertility Center
  • Abington IVF and Genetics Toll Center for Reprodcution
  • Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island
  • Seattle Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

No Intervention

Active Comparator

Experimental

No Intervention

Arm Label

1

2

3

4

5

Arm Description

HBA score over 65% control

HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)

HBA score over 65%. PICSI dish is used to select the sperm for ICSI.

HBA score less than 65%. PICSI dish used to select sperm for ICSI.

HBA Score less than 65%. Control

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Secondary Outcome Measures

Full Information

First Posted
August 25, 2008
Last Updated
December 26, 2010
Sponsor
Biocoat
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1. Study Identification

Unique Protocol Identification Number
NCT00741494
Brief Title
Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Biocoat

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Factor Infertility
Keywords
infertility, ICSI, hyaluronan binding, sperm, sperm selection, male factor, hyaluronan, sperm maturity, clinical pregnancy rates, hyaluronan binding assay, HBA, PICSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
801 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
HBA score over 65% control
Arm Title
2
Arm Type
No Intervention
Arm Description
HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)
Arm Title
3
Arm Type
Active Comparator
Arm Description
HBA score over 65%. PICSI dish is used to select the sperm for ICSI.
Arm Title
4
Arm Type
Experimental
Arm Description
HBA score less than 65%. PICSI dish used to select sperm for ICSI.
Arm Title
5
Arm Type
No Intervention
Arm Description
HBA Score less than 65%. Control
Intervention Type
Device
Intervention Name(s)
PICSI dish
Intervention Description
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
8 weeks post ICSI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Worrilow, Ph.D.
Organizational Affiliation
Biocoat
Official's Role
Study Director
Facility Information:
Facility Name
Huntington Reproductive Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Reproductive Science Center of the Bay Area
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Georgia Reproductive Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Reproductive Biology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Fertility Centers of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
CNY Fertility Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13205
Country
United States
Facility Name
Abington IVF and Genetics Toll Center for Reprodcution
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Seattle Reproductive Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23203216
Citation
Worrilow KC, Eid S, Woodhouse D, Perloe M, Smith S, Witmyer J, Ivani K, Khoury C, Ball GD, Elliot T, Lieberman J. Use of hyaluronan in the selection of sperm for intracytoplasmic sperm injection (ICSI): significant improvement in clinical outcomes--multicenter, double-blinded and randomized controlled trial. Hum Reprod. 2013 Feb;28(2):306-14. doi: 10.1093/humrep/des417. Epub 2012 Nov 30.
Results Reference
derived

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

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