Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

Sponsor
Georgios Papadakis
Study ID
NCT05586802
Phase
PHASE3
Status
Recruiting
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Conditions

  • Klinefelter Syndrome

Eligibility Criteria

Sex
MALE
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 21, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Group 1 (Fertility) - positive micro-dissection testicular sperm extraction (mTESE) biopsy 1
    Men with Klinefelter syndrome seeking fertility or interested in fertility preservation that undergo mTESE biopsy after wash-out of testosterone replacement therapy and have positive sperm retrieval (detectable spermatozoids)
  • Experimental: Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm A
    Men with Klinefelter syndrome seeking fertility or interested in fertility preservation that undergo mTESE biopsy after wash-out of testosterone replacement therapy and have negative sperm retrieval (no detectable spermatozoids), subsequently randomized to receive an hormonal stimulation for 26 weeks
  • Experimental: Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm B
    Men with Klinefelter syndrome seeking fertility or interested in fertility preservation that undergo mTESE biopsy after wash-out of testosterone replacement therapy and have negative sperm retrieval (no detectable spermatozoids), subsequently randomized to receive an hormonal stimulation for 26 weeks
  • Active Comparator: Group 2 (Metabolic Risk) - randomized to Arm C
    Men with Klinefelter syndrome not interested in fertility that present with high metabolic risk and consent to a wash-out of testosterone replacement therapy. They are subsequently randomized to receive an hormonal treatment to improve metabolic health. This arm will receive an active comparator by a testosterone gel
  • Experimental: Group 2 (Metabolic Risk) - randomized to Arm D
    Men with Klinefelter syndrome not interested in fertility that present with high metabolic risk and consent to a wash-out of testosterone replacement therapy. They are subsequently randomized to receive an hormonal treatment to improve metabolic health. This arm will receive an an experimental treatment
  • Experimental: Group 2 (Metabolic Risk) - randomized to Arm E
    Men with Klinefelter syndrome not interested in fertility that present with high metabolic risk and consent to a wash-out of testosterone replacement therapy. They are subsequently randomized to receive an hormonal treatment to improve metabolic health. This arm will receive an an experimental treatment

Primary Outcome Measure

Design 1 : sperm retrieval rate at mTESE biopsy [ Time Frame: mTESE biopsy 26 weeks after hormonal intervention ]

Central Contacts

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