Effect of alpha lipoic acid on male infertility

The effect of alpha lipoic acid on sperm parameters, DNA integrity and oxidative stress in infertile men with increased level of sperm DNA damage

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190406043177N1

Enrollment

Registered

2019-08-21

Start date

2018-06-22

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility. Male infertility

Interventions

Intervention 1: Control group: 3 month usage of placebo. Intervention 2: Intervention group: 3 month usage of 2 Cap. 300 mg alpha lipoic acid Bd before Breakfast and Lunch.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Infertile men with normal sperm parameters and high levels of DNA fragmentation (SCSA>30 , TUNEL>15) Infertile men with abnormal sperm parameters and high levels of DNA fragmentation (SCSA>30 , TUNEL>15)

Exclusion criteria

Exclusion criteria: Varicocele Leukocytospermia cancer and chemotherapy cytotoxic medicine usage

Design outcomes

Primary

Measure	Time frame
DNA Damage. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow cytometry device. Fluorescence and optic microscope.;Sperm motility. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: CASA Device.;Sperm morphology. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: microscope.;Sperm count. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: neobar lam.;Sperm vitality. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: microscope.;Lipid peroxidation (MDA level). Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: spectrophotometer.;Mitochondrial membrane potential. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device.;TAC. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader.;SOD. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader.;GPX. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader.;ROS. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device.;Chromatin evaluation. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device.	—

Measure

Time frame

DNA Damage. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow cytometry device. Fluorescence and optic microscope.;Sperm motility. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: CASA Device.;Sperm morphology. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: microscope.;Sperm count. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: neobar lam.;Sperm vitality. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: microscope.;Lipid peroxidation (MDA level). Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: spectrophotometer.;Mitochondrial membrane potential. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device.;TAC. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader.;SOD. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader.;GPX. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: ELISA Reader.;ROS. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device.;Chromatin evaluation. Timepoint: Before starting the intervention - after 3 month use of medicine or placebo. Method of measurement: Flow Cytometry device.

—

Secondary

Measure	Time frame
Fertilization Rate. Timepoint: After Treatment. Method of measurement: Patient Flow up and Fertility Tests.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Mohammad Hossein Nasr Esfahani

Royan Institute

mh.nasr-esfahani@royaninstitute.org+98 31 9501 5682

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026