Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality

Study Overview
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Brief Summary
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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.

Official Title
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Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality: Post-hoc Analyses From a Double-blind Placebo-controlled Trial

Conditions
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Male Infertility

Intervention / Treatment
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* Dietary Supplement: Proxeed
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proxeed arm<br>Subjects received 2 packets per day for 6 months of supplement (1000 mg of L-carnitine, 725 mg of fumarate, 500 mg of acetyl-L-carnitine, 1000 mg of fructose, 50 mg of citric acid, 50 µg of selenium, 20 mg of coenzyme Q10, 90 mg of vitamin C, 10 mg of zinc, 200 µg of folic acid and 1.5 µg of vitamin B12) | Dietary Supplement: Proxeed<br>* Treatment with dietary supplement for male infertility for Proxeed Arm<br>|
| Placebo Comparator: Placebo arm<br>Subjects received 2 packets per day for 6 months of placebo | Other: Placebo<br>* Treatment with placebo for Placebo Arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sperm concentration (millions/ml) on spermogram of infertile men | 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. | 6 months | 
| Evaluation of sperm motility (%) on spermogram of infertile men | 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. | 6 months | 
| Evaluation of sperm normal morphology (%) on spermogram of infertile men | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pregnancy rate (number) | Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions | 6 months |