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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Experimental | Letrozole 2.5 mg administered orally once daily for 3 months. |
|
| L-Carnitine Monotherapy | Experimental | L-Carnitine 1000 mg administered orally once daily for 3 months. |
|
| Combination Therapy | Experimental | Letrozole 2.5 mg plus L-Carnitine 1000 mg administered orally once daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole 2.5mg | Drug | Letrozole 2.5 mg tablet administered orally once daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sperm concentration (×10⁶/mL) after 3 months of treatment | Change in sperm concentration from baseline to 3 months post-treatment | 3 months |
| Progressive sperm motility (%) after 3 months of treatment | Change in progressive motility from baseline to 3 months post-treatment | 3 months |
| Normal sperm morphology (%) after 3 months of treatment | Change in normal morphology from baseline to 3 months post-treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum testosterone and estradiol levels after 3 months of treatment | Change in hormonal profile from baseline to 3 months post-treatment | 3 months |
| Sperm DNA fragmentation index (DFI) after 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with improved sperm parameters (concentration, motility, morphology) after treatment | Proportion of patients showing clinical improvement in at least one sperm parameter | 3 months |
| Incidence of treatment-related adverse events |
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)
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| Name | Affiliation | Role |
|---|---|---|
| Azim Hedayatpour, Professor, PhD | Tehran University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shariati Hospital, Tehran University of Medical Sciences | Tehran | 1417613151 | Iran |
Due to the specific nature of the data and restrictions from the ethics committee, individual participant data (IPD) will not be shared.
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Participants were randomly assigned to three parallel groups: Letrozole alone, L-Carnitine alone, or combination therapy.
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All participants, care providers, investigators, and outcome assessors were blinded to group allocation.
| L-carnitine | Drug | L-Carnitine 1000 mg capsule administered orally once daily for 3 months. |
|
Change in DFI from baseline to 3 months post-treatment
| 3 months |
| Total antioxidant capacity (TAC) and reactive oxygen species (ROS) levels after 3 months of treatment | Total antioxidant capacity (TAC) and reactive oxygen species (ROS) levels after 3 months of treatment | 3 months |
| Mitochondrial membrane potential (MMP) after 3 months of treatment | Change in MMP from baseline to 3 months post-treatment | 3 months |
| Fertilization rate and embryo quality after ICSI | Assessment of fertilization rate and embryo quality following ICSI | 3 months |
Monitoring and recording of any adverse events related to the study interventions
| 3 months |
| Pregnancy outcomes (biochemical and clinical) following ICSI | Assessment of biochemical and clinical pregnancy rates after embryo transfer | 3 months |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D009845 | Oligospermia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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