Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

What Was Tested

In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin) and Semaglutide.

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.

It had six arms (groups): Group 1 (Fertility) - positive micro-dissection testicular sperm extraction (mTESE) biopsy 1 (no intervention), Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm A (experimental), Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm B (experimental), Group 2 (Metabolic Risk) - randomized to Arm C (active comparator) and Group 2 (Metabolic Risk) - randomized to Arm D (experimental).

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).

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.

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 150 planned participants were the target.

It was open to men only aged from 16 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of Klinefelter syndrome (47,XXY or mosaicism). 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.

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: known or suspected non-compliance, drug or alcohol abuse; inability to follow the procedures of the study (language problems, severe psychological or mental disorders).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2023-03-21 with completion listed for 2027-04-30.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Design 1 : sperm retrieval rate at mTESE biopsy (time frame: mTESE biopsy 26 weeks after hormonal intervention). Design 2 : change in insulin resistance index (HOMA-IR) (time frame: From baseline to week 26 of intervention).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) and Semaglutide in 150 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page and the Semaglutide compound page, all human trials.