Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
NCT ID: NCT00741494
Last Updated: 2010-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
801 participants
INTERVENTIONAL
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
HBA score over 65% control
No interventions assigned to this group
2
HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)
No interventions assigned to this group
3
HBA score over 65%. PICSI dish is used to select the sperm for ICSI.
PICSI dish
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
4
HBA score less than 65%. PICSI dish used to select sperm for ICSI.
PICSI dish
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
5
HBA Score less than 65%. Control
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PICSI dish
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biocoat
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Biocoat, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathryn Worrilow, Ph.D.
Role: STUDY_DIRECTOR
Biocoat
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntington Reproductive Center
Laguna Hills, California, United States
Reproductive Science Center of the Bay Area
San Ramon, California, United States
Georgia Reproductive Specialists
Atlanta, Georgia, United States
Reproductive Biology Associates
Atlanta, Georgia, United States
Fertility Centers of Illinois
Chicago, Illinois, United States
CNY Fertility Center
Syracuse, New York, United States
Abington IVF and Genetics Toll Center for Reprodcution
Abington, Pennsylvania, United States
Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Seattle Reproductive Medicine
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008PICSI03
Identifier Type: -
Identifier Source: org_study_id