Fertility Preservation in Cases of Klinefelter Syndrome.

Study Overview
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Brief Summary
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Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since 1997, more than one hundred births are described. As some studies shown a decrease of successful sperm retrieval with the increasing of age, we plan to compare the potential of sperm retrieval between two groups adult (23-55 years) and young after the onset of puberty (15-22 years). The study will be performed by searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

Official Title
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Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)

Conditions
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Klinefelter Syndrome

Intervention / Treatment
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* Procedure: Seminal analyses and testicular biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Klinefelter Syndrome with 47,XXY non-mosaic Androgenotherapy stopped since more than 6 months Exclusion Criteria: Antecedent of Radiotherapy or chemotherapy Psychological trouble Treatment interfering with spermatogenesis Androgenotherapy non stopped

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young group<br>Patient aged 15-22 years for seminal analyses and testicular biopsy | Procedure: Seminal analyses and testicular biopsy<br>* Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.<br>|
| Other: Adult group<br>Patient aged 23-55 years for seminal analyses and testicular biopsy | Procedure: Seminal analyses and testicular biopsy<br>* Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEsticular Sperm Extraction (TESE) | Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the Young group compare to Adult group. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androgenotherapy | Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment | 15 months | 
| Prognosis factors | Identification of prognosis factors of sperm retrieval (by TESE) in the two groups Young and Adult | 15 months | 
| Histopathologist analyses | Histopathologist analyses of testicular biopsy in the two groups Young and Adult. In the 2 groups, comparison of cases with and without sperm. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Klinefelter Syndrome, Azoospermia, Seminal analyses, Testicular biopsy