Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
Male Factor Infertility
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
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
No Intervention
No Intervention
Active Comparator
Experimental
No Intervention
1
2
3
4
5
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