Trial record 2 of 10 for:    Open Studies | "Klinefelter Syndrome"

Fertility Preservation in Cases of Klinefelter Syndrome. (FERTIPRESERVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01918280
First received: August 6, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Klinefelter Syndrome
Procedure: Seminal analyses and testicular biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • TEsticular Sperm Extraction (TESE) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.


Secondary Outcome Measures:
  • Androgenotherapy [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment

  • Prognosis factors [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Identification of prognosis factors of sperm retrieval (by TESE) in the two groups "Young" and "Adult"

  • Histopathologist analyses [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Histopathologist analyses of testicular biopsy in the two groups "Young" and "Adult". In the 2 groups, comparison of cases with and without sperm.


Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Young group
15-22 years
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.
Adult group
23-55 years
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.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918280

Contacts
Contact: Ingrid PLOTTON, MD 472 12 96 81 ext +33 ingrid.plotton@chu-lyon.fr

Locations
France
Service d'Endocrinologie Moléculaire et Maladies Rares, Centre de Biologie Est, Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Ingrid PLOTTON, MD    472 12 96 81 ext +33    ingrid.plotton@chu-lyon.fr   
Principal Investigator: Ingrid PLOTTON, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Ingrid PLOTTON, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01918280     History of Changes
Other Study ID Numbers: 2009.576
Study First Received: August 6, 2013
Last Updated: January 15, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
Klinefelter Syndrome
Azoospermia
Seminal analyses
Testicular biopsy

Additional relevant MeSH terms:
Klinefelter Syndrome
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism

ClinicalTrials.gov processed this record on July 23, 2014