Fertility Preservation in Cases of Klinefelter Syndrome.

Klinefelter Syndrome Clinical Trial

— FERTIPRESERVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918280
• Other study ID #: 2009.576
• Status: Completed
• Phase: N/A
• Start date: September 20, 2010
• Est. completion date: September 17, 2018

Study information

• Verified date: January 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Klinefelter Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Androgenotherapy	Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment	15 months
Secondary	Prognosis factors	Identification of prognosis factors of sperm retrieval (by TESE) in the two groups "Young" and "Adult"	15 months
Secondary	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