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

University of Roma La Sapienza

Status: Completed

Conditions: Male Infertility

Treatments: Other: Placebo; Dietary Supplement: Proxeed

Study type: Interventional

Funder types: Other

Identifiers

NCT04177667

PXP-001A

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups, including a placebo group

Proxeed arm

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Proxeed

Placebo arm

Placebo Comparator group

Description:

Subjects received 2 packets per day for 6 months of placebo

Treatment:

Other: Placebo