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OpenTrials
Completed

NCT Number: NCT00741494

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

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).

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Key information

Conditions

Male Factor Infertility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntington Reproductive Center, Laguna Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

picsi dish

Device

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

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 8 weeks post ICSI

Sponsors and collaborators

Lead sponsor

Biocoat

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 26, 2008
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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