Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality
Primary Purpose
Male Infertility
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proxeed
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Proxeed arm
Placebo arm
Arm 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)
Subjects received 2 packets per day for 6 months of placebo
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Evaluation of pregnancy rate (number)
Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions
Full Information
NCT ID
NCT04177667
First Posted
November 19, 2019
Last Updated
November 22, 2019
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT04177667
Brief Title
Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind placebo controlled trial
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proxeed arm
Arm Type
Active Comparator
Arm 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)
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Subjects received 2 packets per day for 6 months of placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Proxeed
Intervention Description
Treatment with dietary supplement for male infertility for Proxeed Arm
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Treatment with placebo for Placebo Arm
Primary Outcome Measure Information:
Title
Evaluation of sperm concentration (millions/ml) on spermogram of infertile men
Description
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.
Time Frame
6 months
Title
Evaluation of sperm motility (%) on spermogram of infertile men
Description
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.
Time Frame
6 months
Title
Evaluation of sperm normal morphology (%) on spermogram of infertile men
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluation of pregnancy rate (number)
Description
Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality
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