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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT04177667

Collaborator

(none)

104

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Male Infertility	Dietary Supplement: Proxeed Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double-blind placebo controlled trial

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Jun 30, 2015

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Evaluation of sperm concentration (millions/ml) on spermogram of infertile men [6 months]
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.
Evaluation of sperm motility (%) on spermogram of infertile men [6 months]
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.
Evaluation of sperm normal morphology (%) on spermogram of infertile men [6 months]
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.

Secondary Outcome Measures

Evaluation of pregnancy rate (number) [6 months]
Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ettore De Berardinis, Principal Investigator, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT04177667

Other Study ID Numbers:

PXP-001A

First Posted:

Nov 26, 2019

Last Update Posted:

Nov 26, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Male

Study Results

No Results Posted as of Nov 26, 2019