Clinical trial

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

Recruiting now · Phase 3 · 1 countries · Registry ID NCT05586802

Recruiting nowPhase 3Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age16 Years to 65 Years

SexMale

Healthy volunteersNot accepted

ConditionKlinefelter Syndrome

Full registry 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)

Treatments and study arms

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

Semaglutide

Drug

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

human chorionic gonadotropin

Drug

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

Testosterone gel

Drug

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

Primary outcomes

Design 1 : sperm retrieval rate at mTESE biopsymTESE biopsy 26 weeks after hormonal intervention

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

Design 2 : change in insulin resistance index (HOMA-IR)From baseline to week 26 of intervention

HOMA-IR calculated using fasting glucose and insulin levels

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Service of Endocrinology, Diabetes & Metabolism🇨🇭 Lausanne, Switzerland

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GEORGIOS PAPADAKIS, PD Dr medContact

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