Clinical Trial: Fertility Preservation in Cases of Klinefelter Syndrome.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: TEsticular Sperm Extraction (TESE) [ Time Frame: 15 months ]

Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: August 6, 2013
Date Started: September 2010
Date Completion: June 2018
Last Updated: August 5, 2016
Last Verified: August 2016