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

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

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.

Study Overview

• Status: Completed
• Conditions: Male Infertility
• Intervention / Treatment: Dietary supplement: Proxeed; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Dietary supplement: Proxeed; Treatment with dietary supplement for male infertility for Proxeed Arm
Placebo Comparator: Placebo arm; Subjects received 2 packets per day for 6 months of placebo	Other: Placebo; Treatment with placebo for Placebo Arm

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: PXP-001A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No