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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00484081 |
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Date of registration:
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06/06/2007 |
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Primary sponsor: |
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Public title:
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Microdissection Testicular Sperm Extraction (MicroTESE) and IVF-ICSI Outcome in Non-Obstructive Azoospermia (NOA)
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Scientific title:
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Prospective Evaluation of Microdissection Testicular Sperm Extraction in Non-Obstructive Azoospermic Men and Their IVF-ICSI Related Outcomes at ART Treatment. |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00484081 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Pedro Ravizzini, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinic and Research Center in Human Reproduction Roger Abdelmassih |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men undergoing ART treatment with clinical diagnosis of non-obstructive azoospermia.
- Female partner undergoing ICSI based ART treatment
Exclusion Criteria:
- Men where non-obstructive azoospermia was not confirmed based on histological analysis of fixed testicular tissue specimens collected by open surgical testicular biopsy and stained with haematoxylin and eosin.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Azoospermia
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Infertility
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Intervention(s)
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Procedure: ICSI
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Procedure: Microdissection Testicular Sperm Extraction
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Primary Outcome(s)
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Sperm retrieval rate,mean male and female partner age,mean ICSI and fertilized oocytes, implantation, pregnancy and miscarriage rates.Testicular histology was also compared.
[Time Frame: 17 months]
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Secondary Outcome(s)
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Sperm retrieval associated to pre-operative serum FSH, LH, Total Testosterone,Prolactin, testicular volume and post-operative testicular histology. ICSI and pregnancy results associated to sperm motility.
[Time Frame: 17 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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