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

Biocoat

Status: Completed

Conditions: Male Factor Infertility

Treatments: Device: PICSI dish

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741494

2008PICSI03

Details and patient eligibility

About

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).

Enrollment: 801 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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801 participants in 5 patient groups

1

No Intervention group

Description:

HBA score over 65% control

2

No Intervention group

Description:

HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)

3

Active Comparator group

Description:

HBA score over 65%. PICSI dish is used to select the sperm for ICSI.

Treatment:

Device: PICSI dish

4

Experimental group

Description:

HBA score less than 65%. PICSI dish used to select sperm for ICSI.

Treatment:

Device: PICSI dish

5

No Intervention group

Description:

HBA Score less than 65%. Control