Actively Recruiting
Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
Led by Georgios Papadakis · Updated on 2026-05-11
150
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Klinefelter syndrome (47,XXY or mosaicism)
- For Design 1: Age 16 to 40 years
- For Design 1: Intention to become parent or interest in fertility preservation
- For Design 1: Confirmed azoospermia after centrifugation of one semen sample
- For Design 2: Age 18 to 65 years
- For Design 2: No interest in fertility or fertility preservation
- For Design 2: Hypogonadism at diagnosis or after wash-out of testosterone replacement therapy
- For Design 2: High metabolic risk defined as overweight (BMI 25-28 kg/m2) and insulin resistance (HOMA-IR > 2.6)
You will not qualify if you...
- Contraindications to testosterone-rising therapies such as prostate or breast cancer, PSA > 4 g/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 due to language problems or severe psychological or mental disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Service of Endocrinology, Diabetes & Metabolism
Lausanne, Switzerland, 1011
Actively Recruiting
Research Team
G
GEORGIOS PAPADAKIS, MD
CONTACT
R
RIKIATOU FRANCIOLI, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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