Status:
COMPLETED
Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
Lead Sponsor:
Biocoat
Conditions:
Male Factor Infertility
Eligibility:
All Genders
18-40 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT00741494
Start Date
August 1 2008
Last Update
December 28 2010
Active Locations (9)
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1
Huntington Reproductive Center
Laguna Hills, California, United States, 92653
2
Reproductive Science Center of the Bay Area
San Ramon, California, United States, 94583
3
Georgia Reproductive Specialists
Atlanta, Georgia, United States, 30342
4
Reproductive Biology Associates
Atlanta, Georgia, United States, 30342