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

Male Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177667
• Other study ID #: PXP-001A
• Status: Completed
• Phase: N/A
• Start date: December 1, 2014
• Est. completion date: November 30, 2017

Study information

• Verified date: November 2019
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 30, 2017
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Dietary Supplement:
• Proxeed
Treatment with dietary supplement for male infertility for Proxeed Arm

Other:
• Placebo
Treatment with placebo for Placebo Arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Evaluation of pregnancy rate (number)	Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions	6 months