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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Male Factor Infertility

Intervention / Treatment
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* Device: PICSI dish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>HBA score over 65% control | |
| No Intervention: 2<br>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<br>HBA score over 65%. PICSI dish is used to select the sperm for ICSI. | Device: PICSI dish<br>* Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI<br>|
| Experimental: 4<br>HBA score less than 65%. PICSI dish used to select sperm for ICSI. | Device: PICSI dish<br>* Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI<br>|
| No Intervention: 5<br>HBA Score less than 65%. Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 8 weeks post ICSI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, ICSI, hyaluronan binding, sperm, sperm selection, male factor, hyaluronan, sperm maturity, clinical pregnancy rates, hyaluronan binding assay, HBA, PICSI