An interventional study of Seminal analyses and testicular biopsy in Klinefelter Syndrome, sponsored by Hospices Civils de Lyon. Completed at 4 sites in France. Open to male participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Patient aged 15-22 years for seminal analyses and testicular biopsy
Procedure: Seminal analyses and testicular biopsy
Patient aged 23-55 years for seminal analyses and testicular biopsy
Procedure: Seminal analyses and testicular biopsy
Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.
TEsticular Sperm Extraction (TESE)
Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.
Time frame: 15 months
Androgenotherapy
Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment
Time frame: 15 months
Prognosis factors
Identification of prognosis factors of sperm retrieval (by TESE) in the two groups "Young" and "Adult"
Time frame: 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.
Time frame: 15 months
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon