Fertility Preservation in Cases of Klinefelter Syndrome.

Not Applicable

Completed

• Conditions: Klinefelter Syndrome
• Interventions: Procedure: Seminal analyses and testicular biopsy

• Registration Number: NCT01918280
• Lead Sponsor: Hospices Civils de Lyon

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 Description

Not available

Study Timeline

• Study Start: 2010-09-20
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-07
• Primary Completion: 2018-09-17
• Study Completion: 2018-09-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Young group	Seminal analyses and testicular biopsy	Patient aged 15-22 years for seminal analyses and testicular biopsy
Adult group	Seminal analyses and testicular biopsy	Patient aged 23-55 years for seminal analyses and testicular biopsy

Primary Outcome Measures

Name	Time	Method
TEsticular Sperm Extraction (TESE)	15 months	Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.

Secondary Outcome Measures

Name	Time	Method
Androgenotherapy	15 months	Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment
Prognosis factors	15 months	Identification of prognosis factors of sperm retrieval (by TESE) in the two groups "Young" and "Adult"
Histopathologist analyses	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.

Trial Locations

Locations (4)

Service de Biologie de la Reproduction - CECOS - Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Service d'Endocrinologie Moléculaire et Maladies Rares, Centre de Biologie Est, Hospices Civils de Lyon; 🇫🇷 Bron, France

Service de Biologie de la Reproduction - Hôpital de la Conception; 🇫🇷 Marseille, France

Groupe de Médecine de la Reproduction - CECOS Midi-Pyrénées - Hôpital Paule de Viguier); 🇫🇷 Toulouse, France