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Fertility Preservation in Cases of Klinefelter Syndrome.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01918280
Acronym
FERTIPRESERVE
Enrollment
141
Registered
2013-08-07
Start date
2010-09-20
Completion date
2018-09-17
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Klinefelter Syndrome

Keywords

Klinefelter Syndrome, Azoospermia, Seminal analyses, Testicular biopsy

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.

Interventions

PROCEDURESeminal analyses and testicular biopsy

Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
15 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TEsticular Sperm Extraction (TESE)15 monthsImprovement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the Young group compare to Adult group.

Secondary

MeasureTime frameDescription
Prognosis factors15 monthsIdentification of prognosis factors of sperm retrieval (by TESE) in the two groups Young and Adult
Androgenotherapy15 monthsInfluence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment
Histopathologist analyses15 monthsHistopathologist analyses of testicular biopsy in the two groups Young and Adult. In the 2 groups, comparison of cases with and without sperm.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026