Idiopathic Oligoasthenoteratozoospermia, Male Infertility
Conditions
Keywords
Oligoasthenoteratozoospermia, Male Infertility, Letrozole, L-Carnitine, Oxidative Stress, Sperm Quality, ART, ICSI
Brief summary
This is a randomized clinical trial evaluating the efficacy of Letrozole, L-Carnitine, and their combination on sperm quality, oxidative stress, and ART outcomes in men with idiopathic oligoasthenoteratozoospermia.
Detailed description
This three-arm randomized controlled trial included 90 men with idiopathic oligoasthenoteratozoospermia (iOAT) who were assigned to receive Letrozole (2.5 mg/day), L-Carnitine (1000 mg/day), or combination therapy for 3 months. Sperm parameters, hormonal profiles, oxidative stress biomarkers, mitochondrial function, and ICSI outcomes were assessed before and after treatment.
Interventions
DRUGLetrozole 2.5mg
Letrozole 2.5 mg tablet administered orally once daily for 3 months.
DRUGL-carnitine
L-Carnitine 1000 mg capsule administered orally once daily for 3 months.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants, care providers, investigators, and outcome assessors were blinded to group allocation.
Intervention model description
Participants were randomly assigned to three parallel groups: Letrozole alone, L-Carnitine alone, or combination therapy.
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of idiopathic oligoasthenoteratozoospermia (iOAT) per WHO 2021 criteria Age 20 to 45 years BMI between 18 and 30 kg/m² No prior hormonal therapy or antioxidant supplements within the last 3 months
Exclusion criteria
Varicocele, cryptorchidism, or genital tract infection Hormonal disorders (hypogonadism, hyperprolactinemia, thyroid dysfunction) Smoking, alcohol use, or drug abuse Use of testosterone or anabolic steroids within the last 6 months Female partner with severe infertility factors (age ≥40, tubal blockage, severe endometriosis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm concentration (×10⁶/mL) after 3 months of treatment | 3 months | Change in sperm concentration from baseline to 3 months post-treatment |
| Progressive sperm motility (%) after 3 months of treatment | 3 months | Change in progressive motility from baseline to 3 months post-treatment |
| Normal sperm morphology (%) after 3 months of treatment | 3 months | Change in normal morphology from baseline to 3 months post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum testosterone and estradiol levels after 3 months of treatment | 3 months | Change in hormonal profile from baseline to 3 months post-treatment |
| Sperm DNA fragmentation index (DFI) after 3 months of treatment | 3 months | Change in DFI from baseline to 3 months post-treatment |
| Total antioxidant capacity (TAC) and reactive oxygen species (ROS) levels after 3 months of treatment | 3 months | Total antioxidant capacity (TAC) and reactive oxygen species (ROS) levels after 3 months of treatment |
| Mitochondrial membrane potential (MMP) after 3 months of treatment | 3 months | Change in MMP from baseline to 3 months post-treatment |
| Fertilization rate and embryo quality after ICSI | 3 months | Assessment of fertilization rate and embryo quality following ICSI |
Countries
Iran
Contacts
STUDY_CHAIRAzim Hedayatpour, Professor, PhD
Tehran University of Medical Sciences
Outcome results
None listed