Clinical trial NCT00741494: Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Factor Infertility
Keywords: infertility
ICSI
hyaluronan binding
sperm
sperm selection
male factor
hyaluronan
sperm maturity
clinical pregnancy rates
hyaluronan binding assay
HBA
PICSI
Lead sponsor: Biocoat
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 801
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 8 weeks post ICSI
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Huntington Reproductive Center
state: California
city: San Ramon
country: United States
facility: Reproductive Science Center of the Bay Area
state: California
city: Atlanta
country: United States
facility: Georgia Reproductive Specialists
state: Georgia
city: Atlanta
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Chicago
country: United States
facility: Fertility Centers of Illinois
state: Illinois
city: Syracuse
country: United States
facility: CNY Fertility Center
state: New York
city: Abington
country: United States
facility: Abington IVF and Genetics Toll Center for Reprodcution
state: Pennsylvania
city: Providence
country: United States
facility: Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island
state: Rhode Island
city: Seattle
country: United States
facility: Seattle Reproductive Medicine
state: Washington
Study officials:
affiliation: Biocoat
name: Kathryn Worrilow, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.