Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fertility Preservation in Cases of Klinefelter Syndrome. (FERTIPRESERVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01918280
Recruitment Status : Active, not recruiting
First Posted : August 7, 2013
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE August 6, 2013
First Posted Date  ICMJE August 7, 2013
Last Update Posted Date January 4, 2019
Actual Study Start Date  ICMJE September 2010
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01918280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
  • Androgenotherapy [ Time Frame: 15 months ]
    Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment
  • Prognosis factors [ Time Frame: 15 months ]
    Identification of prognosis factors of sperm retrieval (by TESE) in the two groups "Young" and "Adult"
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fertility Preservation in Cases of Klinefelter Syndrome.
Official Title  ICMJE Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Klinefelter Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Young group
    Patient aged 15-22 years for seminal analyses and testicular biopsy
    Intervention: Procedure: Seminal analyses and testicular biopsy
  • Adult group
    Patient aged 23-55 years for seminal analyses and testicular biopsy
    Intervention: Procedure: Seminal analyses and testicular biopsy
Publications * Plotton I, Giscard d'Estaing S, Cuzin B, Brosse A, Benchaib M, Lornage J, Ecochard R, Dijoud F, Lejeune H; FERTIPRESERVE group. Preliminary results of a prospective study of testicular sperm extraction in young versus adult patients with nonmosaic 47,XXY Klinefelter syndrome. J Clin Endocrinol Metab. 2015 Mar;100(3):961-7. doi: 10.1210/jc.2014-3083. Epub 2014 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01918280
Other Study ID Numbers  ICMJE 2009.576
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ingrid PLOTTON, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP