Male Factor Infertility
Conditions
Keywords
infertility, ICSI, hyaluronan binding, sperm, sperm selection, male factor, hyaluronan, sperm maturity, clinical pregnancy rates, hyaluronan binding assay, HBA, PICSI
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).
Interventions
DEVICEPICSI dish
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
Sponsors
Biocoat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate | 8 weeks post ICSI |
Countries
United States
Outcome results
None listed