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:
Biocoat
Information provided by:
Biocoat
ClinicalTrials.gov Identifier:
NCT00741494
First received: August 25, 2008
Last updated: December 26, 2010
Last verified: December 2010
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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
Additional 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 May 23, 2013