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

Sponsor

Biocoat (Industry)

Overall Status

Completed

CT.gov ID

NCT00741494

Collaborator

(none)

801

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Male Factor Infertility	Device: PICSI dish	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

801 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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)

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 HBA score over 65% control
No Intervention: 2 HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)
Active Comparator: 3 HBA score over 65%. PICSI dish is used to select the sperm for ICSI.	Device: PICSI dish Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
Experimental: 4 HBA score less than 65%. PICSI dish used to select sperm for ICSI.	Device: PICSI dish Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
No Intervention: 5 HBA Score less than 65%. Control

Outcome Measures

Primary Outcome Measures

Clinical pregnancy rate [8 weeks post ICSI]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntington Reproductive Center	Laguna Hills	California	United States	92653
2	Reproductive Science Center of the Bay Area	San Ramon	California	United States	94583
3	Georgia Reproductive Specialists	Atlanta	Georgia	United States	30342
4	Reproductive Biology Associates	Atlanta	Georgia	United States	30342
5	Fertility Centers of Illinois	Chicago	Illinois	United States	60610
6	CNY Fertility Center	Syracuse	New York	United States	13205
7	Abington IVF and Genetics Toll Center for Reprodcution	Abington	Pennsylvania	United States	19001
8	Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02903
9	Seattle Reproductive Medicine	Seattle	Washington	United States	98109