Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

Launched by GEORGIOS PAPADAKIS · Oct 15, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome," is investigating how certain treatments can improve health for men with Klinefelter Syndrome (KFS), a genetic condition caused by an extra X chromosome. The researchers want to see if using aromatase inhibitors, which help balance hormones, can enhance metabolic health and the ability to produce sperm compared to current treatments. They also aim to learn more about the different ways KFS affects men by analyzing genetic and metabolic information, and they will explore the effects of weight loss medication and additional hormone treatments on sperm production.

To participate, men aged 16 to 65 with a confirmed diagnosis of Klinefelter syndrome may be eligible. This includes younger men interested in having children and older men who are not focused on fertility but have metabolic health issues, such as being overweight or having insulin resistance. Participants can expect to undergo various assessments and treatments during the study, and they will be closely monitored for their health outcomes. It's important to note that certain health issues, like prostate cancer or severe heart disease, may prevent someone from joining the trial.

Gender

MALE

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)