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

NCT04177667 | Completed

• 1 other identifier: PXP-001A
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Evaluation of pregnancy rate (number)

  6 months

Study Arms (2)

Proxeed arm

ACTIVE COMPARATOR

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

Placebo arm

PLACEBO COMPARATOR

Subjects received 2 packets per day for 6 months of placebo

Other: Placebo

Interventions

Proxeed DIETARY_SUPPLEMENT

Treatment with dietary supplement for male infertility for Proxeed Arm

Proxeed arm

Placebo OTHER

Treatment with placebo for Placebo Arm

Placebo arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind placebo controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 26, 2019
• Study Start: December 1, 2014
• Primary Completion: June 30, 2015
• Study Completion: November 30, 2017
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share