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

Not Applicable

Completed

• Conditions: Male Factor Infertility
• Interventions: Device: PICSI dish

• Registration Number: NCT00741494
• Lead Sponsor: Biocoat

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Last Update Submitted: 2010-12-26
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 801

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	PICSI dish	HBA score less than 65%. PICSI dish used to select sperm for ICSI.
3	PICSI dish	HBA score over 65%. PICSI dish is used to select the sperm for ICSI.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	8 weeks post ICSI

Trial Locations

Locations (9)

Reproductive Biology Associates; 🇺🇸 Atlanta, Georgia, United States

Huntington Reproductive Center; 🇺🇸 Laguna Hills, California, United States

CNY Fertility Center; 🇺🇸 Syracuse, New York, United States

Georgia Reproductive Specialists; 🇺🇸 Atlanta, Georgia, United States

Seattle Reproductive Medicine; 🇺🇸 Seattle, Washington, United States

Reproductive Science Center of the Bay Area; 🇺🇸 San Ramon, California, 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

Fertility Centers of Illinois; 🇺🇸 Chicago, Illinois, United States