Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)

Male Factor Infertility Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741494
• Other study ID #: 2008PICSI03
• Status: Completed
• Phase: N/A
• First received: August 25, 2008
• Last updated: December 26, 2010
• Start date: August 2008

Study information

• Verified date: December 2010
• Source: Biocoat
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Male Factor Infertility

Intervention

Device:
• PICSI dish
Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI

Locations

Country	Name	City	State
United States	Abington IVF and Genetics Toll Center for Reprodcution	Abington	Pennsylvania
United States	Georgia Reproductive Specialists	Atlanta	Georgia
United States	Reproductive Biology Associates	Atlanta	Georgia
United States	Fertility Centers of Illinois	Chicago	Illinois
United States	Huntington Reproductive Center	Laguna Hills	California
United States	Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Reproductive Science Center of the Bay Area	San Ramon	California
United States	Seattle Reproductive Medicine	Seattle	Washington
United States	CNY Fertility Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biocoat

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		8 weeks post ICSI	No