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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
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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

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

    First Posted
    November 19, 2019
    Last Updated
    November 22, 2019
    Sponsor
    University of Roma La Sapienza
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    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

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

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