SemenGlutide: A randomized double-blinded, placebo-controlled, single-center, clinical trial comparing the effects of s.c. Semaglutide 2.4 mg once-weekly versus placebo on sperm concentration in overweight infertile men

Condition studied

Infertility, overweight

Investigational medicinal product(s)

Eligibility

Primary endpoint

Difference in sperm production evaluated by sperm concentration (millions/mL) or total sperm count (millions) at day 200 in Semaglutide- compared to placebo-treated men

Endpoint detail

Differences in sperm concentration (millions/mL) (day 100, 300) in Semaglutide- compared to placebo-treated men., Differences in DNA fragmentation index (day 300), Changes in DNA fragmentation index (day 200, 300), Changes in sperm parameters (number, motility, morphology) (day 100, 200, 300), Differences in sperm production (sperm concentration, total sperm count, total motile sperm) evaluated by the automated CASA SCA (Microptic) system (baseline and day 200, 300), Differences in body mass index (BMI) and body weight (day 100, 200, 300), Differences in body composition, total body fat percentage, total muscle mass, evaluated by DXA (day 300), Differences in BMD and TBS evaluated by DXA (day 300), Changes in subjective symptoms of androgen deficiency assessed using Androgen Deficiency in the Aging Male questionnaire (ADAM) (day 300), Changes in male sexual function assessed using The International Index of Erectile Function questionnaire (IIEF-5) (day 300), Changes in serum total testosterone (day 100, 200, 300), Differences in free testosterone (day 100, 200, 300), Differences in serum LH and FSH (day 100, 200, 300), Differences in sex hormone binding globulin (SHBG) (day 100, 200, 300), Differences in serum AMH, inhibin B (day 100, 200, 300, Differences in endocrine testicular function (testosterone/LH and inhibin B/FSH ratios) (day 100, 200, 300), Differences in serum estradiol and testosterone/estradiol ratio (day 100, 200, 300), Differences in HbA1c and HOMA-IR (day 100, 200, 300), Differences in total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides (day 100, 200, 300)