Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05586802
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)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT05586802
Study Brief:
Protocol Section:
NCT05586802