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NCT Number: NCT05586802

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

The study seeks primarily to determine whether modulation of systemic and testicular sex steroids balance by aromatase inhibitors will positively affect the metabolic health and spermatogenesis of men with Klinefelter syndrome (KFS) as compared to the current state of the art for each issue.

Secondary objectives of this study are (i) to unravel the heterogeneity of the reproductive and metabolic phenotype of men with KFS by performing a multi-omic analysis in a large cohort at baseline; (ii) to evaluate the efficacy of semaglutide-induced weight loss to achieve metabolic and reproductive benefit in men with Klinefelter syndrome as compared to standard testosterone replacement; (ii) to assess whether addition of hCG to aromatase inhibitors further increases intratesticular testosterone and promotes spermatogenesis in men with KFS.

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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 Genital Diseases Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Infertility Insulin Resistance Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

16 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Service of Endocrinology, Diabetes & Metabolism

Lausanne, 1011, Switzerland

Location status: Recruiting

Location contact

GEORGIOS PAPADAKIS, PD Dr med

CONTACT

[email protected]

+ 41795560308

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Diagnosis of Klinefelter syndrome (47,XXY or mosaicism)

Design 1:

  • Age range: 16-40 years old
  • Intention to become parent or interest in fertility preservation
  • Confirmed azoospermia (lack of spermatozoids) after centrifugation of one semen sample

Design 2:

  • Age range: 18-65 years old
  • No interest in fertility or fertility preservation
  • Hypogonadism at diagnosis or after wash-out of testosterone replacement therapy
  • High metabolic risk defined as overweight (BMI 25-28 kg/m2) and insulin resistance (HOMA-IR > 2.6)

Exclusion criteria

  • Contraindications to testosterone-rising therapies (prostate or breast cancer, PSA > 4 µg/l, active liver disease, symptomatic heart disease)
  • Decreased life expectancy due to terminal disease
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study (language problems, severe psychological or mental disorders)

Treatment and study plan

Anastrozole

Drug

This will be an experimental treatment for 26 weeks in Group 1 Arm A and Arm B as well for Group 2 Arm D

Other names: Anastrozole Teva

semaglutide

Drug

This will be an experimental treatment for 26 weeks in Group 2 Arm E

Other names: Ozempic

Human Chorionic Gonadotropin

Drug

This will be an experimental treatment for 26 weeks in addition to anastrozole in Group 1 - Arm B

Other names: Choriomon

Testosterone gel

Drug

This will be an active comparator for 26 weeks in Group 2 - Arm C

Other names: Tostran

Primary outcomes

  1. Design 1 : sperm retrieval rate at mTESE biopsy

    Time frame: mTESE biopsy 26 weeks after hormonal intervention

    Sperm retrieval rate at mTESE biopsy (Group A and B)

  2. Design 2 : change in insulin resistance index (HOMA-IR)

    Time frame: From baseline to week 26 of intervention

    HOMA-IR calculated using fasting glucose and insulin levels

Study contacts

Contact information is provided by the study sponsor or research team.

GEORGIOS PAPADAKIS, MD

CONTACT

[email protected]

+41795560308

RIKIATOU FRANCIOLI, MD

CONTACT

[email protected]

+41795562861

Sponsors and collaborators

Lead sponsor

Georgios Papadakis

Other

Registry information

Official study title

Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study

Acronym: KLIN-HEALTH

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2022
Registry last updated
May 11, 2026

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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