Clinical trial NCT01918280: Fertility Preservation in Cases of Klinefelter Syndrome.
Official title: Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Klinefelter Syndrome
Keywords: Klinefelter Syndrome
Azoospermia
Seminal analyses
Testicular biopsy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 141
Sex: MALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: TEsticular Sperm Extraction (TESE)
timeFrame: 15 months
Secondary outcomes:
measure: Androgenotherapy
timeFrame: 15 months
measure: Prognosis factors
timeFrame: 15 months
measure: Histopathologist analyses
timeFrame: 15 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Biologie de la Reproduction - CECOS - Groupe Hospitalier Pellegrin
city: Bron
country: France
facility: Service d'Endocrinologie Moléculaire et Maladies Rares, Centre de Biologie Est, Hospices Civils de Lyon
city: Marseille
country: France
facility: Service de Biologie de la Reproduction - Hôpital de la Conception
city: Toulouse
country: France
facility: Groupe de Médecine de la Reproduction - CECOS Midi-Pyrénées - Hôpital Paule de Viguier)
Study officials:
affiliation: Hospices Civils de Lyon
name: Ingrid PLOTTON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Renault L, Labrune E, Giscard d'Estaing S, Cuzin B, Lapoirie M, Benchaib M, Lornage J, Soignon G, de Souza A, Dijoud F, Fraison E, Pral-Chatillon L, Bordes A, Sanlaville D, Schluth-Bolard C, Salle B, Ecochard R, Lejeune H, Plotton I. Delaying testicular sperm extraction in 47,XXY Klinefelter patients does not impair the sperm retrieval rate, and AMH levels are higher when TESE is positive. Hum Reprod. 2022 Oct 31;37(11):2518-2531. doi: 10.1093/humrep/deac203.
citation: Plotton I, Giscard d'Estaing S, Cuzin B, Brosse A, Benchaib M, Lornage J, Ecochard R, Dijoud F, Lejeune H; FERTIPRESERVE group. Preliminary results of a prospective study of testicular sperm extraction in young versus adult patients with nonmosaic 47,XXY Klinefelter syndrome. J Clin Endocrinol Metab. 2015 Mar;100(3):961-7. doi: 10.1210/jc.2014-3083. Epub 2014 Nov 25.