Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anastrozole, Semaglutide, human chorionic gonadotropin, Testosterone gel.
- Who it may be relevant to
- Registry conditions: Klinefelter Syndrome. Basic parameters: 16 years — 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study
Overview
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.
Interventions
- Drug Anastrozole
This will be an experimental treatment for 26 weeks in Group 1 Arm A and Arm B as well for Group 2 Arm D - Drug Semaglutide
This will be an experimental treatment for 26 weeks in Group 2 Arm E - Drug human chorionic gonadotropin
This will be an experimental treatment for 26 weeks in addition to anastrozole in Group 1 - Arm B - Drug Testosterone gel
This will be an active comparator for 26 weeks in Group 2 - Arm C
Primary outcome measures
- Design 1 : sperm retrieval rate at mTESE biopsy [Time frame: mTESE biopsy 26 weeks after hormonal intervention]
- Design 2 : change in insulin resistance index (HOMA-IR) [Time frame: From baseline to week 26 of intervention]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Service of Endocrinology, Diabetes & Metabolism — Lausanne
Identifiers
NCT: NCT05586802 · PZ00P3_202151