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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | HBA score over 65% control | |
| 2 | No Intervention | HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores) | |
| 3 | Active Comparator | HBA score over 65%. PICSI dish is used to select the sperm for ICSI. |
|
| 4 | Experimental | HBA score less than 65%. PICSI dish used to select sperm for ICSI. |
|
| 5 | No Intervention | HBA Score less than 65%. Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICSI dish | Device | Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | 8 weeks post ICSI |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Worrilow, Ph.D. | Biocoat | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Reproductive Center | Laguna Hills | California | 92653 | United States | ||
| Reproductive Science Center of the Bay Area |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23203216 | Derived | 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. |
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| San Ramon |
| California |
| 94583 |
| United States |
| Georgia Reproductive Specialists | Atlanta | Georgia | 30342 | United States |
| Reproductive Biology Associates | Atlanta | Georgia | 30342 | United States |
| Fertility Centers of Illinois | Chicago | Illinois | 60610 | United States |
| CNY Fertility Center | Syracuse | New York | 13205 | United States |
| Abington IVF and Genetics Toll Center for Reprodcution | Abington | Pennsylvania | 19001 | United States |
| Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02903 | United States |
| Seattle Reproductive Medicine | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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