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Completed

NCT Number: NCT01918280

Fertility Preservation in Cases of Klinefelter Syndrome.

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.

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Key information

Conditions

Klinefelter Syndrome Azoospermia Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Gonadal Disorders Hypogonadism Infertility Infertility, Male Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

15 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seminal analyses and testicular biopsy

Procedure

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

Primary outcomes

  1. TEsticular Sperm Extraction (TESE)

    Time frame: 15 months

    Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.

Secondary outcomes

  1. Androgenotherapy

    Time frame: 15 months

    Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment

  2. Prognosis factors

    Time frame: 15 months

    Identification of prognosis factors of sperm retrieval (by TESE) in the two groups "Young" and "Adult"

  3. Histopathologist analyses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: FERTIPRESERVE

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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