Male Infertility
Conditions
Brief summary
Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation. This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.
Interventions
DIETARY_SUPPLEMENTProxeed
Treatment with dietary supplement for male infertility for Proxeed Arm
OTHERPlacebo
Treatment with placebo for Placebo Arm
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind placebo controlled trial
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* men with oligo- and/or astheno- and/or terato-zoospermia * with or without varicocele * men aged between 18 and 50 years * men from couples with history of difficulty conceiving for more than 12 months
Exclusion criteria
* subjects with known hypersensitivity to any of the treatment compound * history of undescended testes or cancer * endocrine disorders * history of post-pubertal mumps * genitourinary surgery * obstructive azoospermia or obstructive pathology of the urogenital system * autoimmune disease * cystic fibrosis * history of taking any therapy affecting fertility within last 3 months * excessive consumption of alcohol or regular use of illicit or recreational drugs * positive serology for HIV * subjects following any special diet * any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of sperm concentration (millions/ml) on spermogram of infertile men | 6 months | Efficacy of the therapy on sperm concentration (millions/ml) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age. |
| Evaluation of sperm motility (%) on spermogram of infertile men | 6 months | Efficacy of the therapy on sperm motility (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age. |
| Evaluation of sperm normal morphology (%) on spermogram of infertile men | 6 months | Efficacy of the therapy on sperm normal morphology (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pregnancy rate (number) | 6 months | Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions |
Outcome results
None listed