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

NCT ID: NCT04177667

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2017-11-30

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.

Conditions

Male Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Proxeed arm

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)

Group Type: ACTIVE_COMPARATOR

Proxeed

Intervention Type: DIETARY_SUPPLEMENT

Treatment with dietary supplement for male infertility for Proxeed Arm

Placebo arm

Subjects received 2 packets per day for 6 months of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Treatment with placebo for Placebo Arm

Interventions

Proxeed

Treatment with dietary supplement for male infertility for Proxeed Arm

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Treatment with placebo for Placebo Arm

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Ettore De Berardinis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PXP-001A

Identifier Type: -

Identifier Source: org_study_id