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Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

ConditionKlinefelter Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age16-65
SponsorGeorgios Papadakis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age range: 18-65 years old

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group 1 (Fertility) - positive micro-dissection testicular sperm extraction (mTESE) biopsy 1No intervention 0 interventions
Group B: Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm AExperimental treatment 1 intervention
Group C: Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm BExperimental treatment 2 interventions
Group D: Group 2 (Metabolic Risk) - randomized to Arm CActive comparator 1 intervention
Group E: Group 2 (Metabolic Risk) - randomized to Arm DExperimental treatment 1 intervention
Group F: Group 2 (Metabolic Risk) - randomized to Arm EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Design 1 : sperm retrieval rate at mTESE biopsy

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

Time frame
mTESE biopsy 26 weeks after hormonal intervention
2

Design 2 : change in insulin resistance index (HOMA-IR)

HOMA-IR calculated using fasting glucose and insulin levels

Time frame
From baseline to week 26 of intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgios Papadakis

Lead sponsor

University of Lausanne Hospitals

Sponsor institution

Source ClinicalTrials.gov
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