Administration of Antioxidants to Infertile Men and Sperm Quality (NCT04256278) | Clinical Trial Compass
CompletedNot Applicable
Administration of Antioxidants to Infertile Men and Sperm Quality
Greece80 participantsStarted 2020-02-28
Plain-language summary
The purpose of this randomized clinical trial is to assess the effect of oral antioxidant administration to infertile men, by evaluating semen variables, sperm DFI and levels of ROS. Oral antioxidants or placebo will be given for 3 consecutive months.
The study will recruit infertile men, who have one previous abnormal spermiogram, with at least one pathological variable (concentration, motility, morphology), according to WHO 2010 criteria. Participants will be recruited in the outpatient clinic of the Unit of Human Reproduction and of the Unit of Reproductive Endocrinology at the 1st Ob/Gyn Dept.
Who can participate
Age range18 Years ā 50 Years
SexMALE
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Inclusion criteria
ā. Men, 18-50 years old
ā. Infertility defined as follows:
ā. No treatment for infertility in the last three (3) months
ā. Normal hormone profile (TSH, FSH, LH, total testosterone, prolactin)
ā. Negative culture for mycoplasma or ureaplasma
ā. Physiological scrotal ultrasound
Exclusion criteria
ā. Genetic cause of infertility
ā. History of cryptorchidism
ā. History of orchectomy
ā. History of testicular cancer
ā. History of severe heart, liver or kidney disease
ā. History of endocrine disease (primary or secondary hypogonadism, hyperprolactinemia, thyroid, pituitary or adrenal disease)
What they're measuring
1
Sperm parameters
Timeframe: immediately before treatment initiation
2
Sperm parameters
Timeframe: immediately after the end of a 3 month treatment