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OpenTrials
Completed

NCT Number: NCT01750632

Subcapsular Orchiectomy in Men With Klinefelter Syndrome

Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed testicular tissue is examined for presence of sperm and cryopreserved in small pieces for fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a biobank.

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Key information

Conditions

Klinefelter Syndrome 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 Gonadal Disorders Hypogonadism Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

15 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Clinic, Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Klinefelter
  • 15-40 years of age

Exclusion criteria

  • inability to understand the study

Treatment and study plan

Orchiectomy

Procedure

The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.

Primary outcomes

  1. Presence of testicular sperm

    Time frame: Between 1 and 6 months

Secondary outcomes

  1. Clinical pregnancy rate after ICSI with retrieved testicular sperm

    Time frame: participants will be followed for the duration of fertility treatment, an expected average of 6 months

Other outcomes

  1. Predictive value of FSH and other hormones for the presence of testicular sperm

    Time frame: Between 1 and 6 months

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • University of Copenhagen

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Oct 4, 2016

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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