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Fertility Preservation in Cases of Klinefelter Syndrome. (FERTIPRESERVE)

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Civil Hospices of Lyon

Status

Completed

Conditions

Klinefelter Syndrome

Treatments

Procedure: Seminal analyses and testicular biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT01918280
2009.576

Details and patient eligibility

About

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.

Enrollment

141 patients

Sex

Male

Ages

15 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

141 participants in 2 patient groups

Young group
Experimental group
Description:
Patient aged 15-22 years for seminal analyses and testicular biopsy
Treatment:
Procedure: Seminal analyses and testicular biopsy
Adult group
Other group
Description:
Patient aged 23-55 years for seminal analyses and testicular biopsy
Treatment:
Procedure: Seminal analyses and testicular biopsy

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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