The effect of supplementation with organic selenium on sperm parameters, serum levels of androgens, sexual function, and quality of sexual life in infertile me

Phase 3

• Conditions: Oligoasthenoteratozoospermia.; Male infertility

• Registration Number: IRCT20131009014957N11
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

An infertile married man with idiopathic oligoasthenoteratozoosperm for at least one year
Age 20 to 40 years
No problem in wife fertility
Non-addiction to alcohol and substance abuse

Exclusion Criteria

?Azospermia
Infectious disease and anatomical abnormalities of the genital tract
Varicocele-related infertility
History of pelvic surgeries or need to do so
Cancer, liver and gallbladder diseases, diabetes, thyroid disorders, kidney failure, uncontrolled blood pressure, cerebral hemorrhage, retinal hemorrhage, unilateral testicular atrophy
Abnormal karyotype
History of receiving chemotherapy drugs, corticosteroids, anticoagulants, testosterone, anti-androgens
Taking any chemical or herbal medicine specific to infertility during the project and the previous three months
BMI>=30

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Semen parameters (number, morphology, motility). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: To calculate the number of live sperm, morphology and motility, a light microscope with a magnification of 1000× will be used.;Serum levels of androgens (total testosterone, free testosterone and dehydroepiandrosterone. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using ELISA method by monobind kits.;Sexual function score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: BSFI: Brief Sexual Function Inventory.;Sex quality of life score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Sexual Quality of Life-M: SQOL-M.

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate. Timepoint: 12 weeks after the intervention. Method of measurement: Follow-up for up to two months after the intervention and quantitative Beta-hCG testing if necessary.;Side effects. Timepoint: During and after the intervention. Method of measurement: Questionnaire.;Satisfaction with medication. Timepoint: During and after the intervention. Method of measurement: Satisfaction rate questionnaire.