Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia

Study Overview
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Brief Summary
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This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Detailed Description
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Study approval: The study will be submitted for approval by Research and Ethical committees at Faculty of Medicine, Sohag University. This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART program in Sohag . Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files. Study design: Prospective, controlled clinical study. Control group: ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. Cases with known female factor infertility will be excluded. Outcome Measures: fertilization rate, embryo quality, chemical pregnancy and clinical pregnancy.

Official Title
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Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia

Conditions
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ICSI AZOOSPERMIA VARICOCELE

Intervention / Treatment
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* Procedure: ICSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in aى ART program. ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. Exclusion Criteria: Cases with known female factor infertility
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE<br>ICSI cases using cryopreserved testicular sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART program | Procedure: ICSI<br>* Intracytoplasmic Sperm Injection<br>|
| Experimental: ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE<br>ICSI cases using cryopreserved testicular sperms from infertile azoospermic men due to etiologies other than varicocele | Procedure: ICSI<br>* Intracytoplasmic Sperm Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment. |  | 6/2014 up to one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization Rate: percentage of fertilized oocyte. |  | 6/2014 up to one year. | 
| Embryo Quality: morphological assessment of the developing embryo. |  | 6/2014 up to one year. | 
| Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer. |  | 6/2014 up to one year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VARICOCELE-AZOOSPERMIA-ICSI