Comparative Evaluation of the Efficacy of Letrozole, L-Carnitine, and Their Combination on Sperm Quality, Oxidative Stress, and ART Outcomes in Men With Idiopathic Oligoasthenoteratozoospermia.

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Male Infertility; Idiopathic Oligoasthenoteratozoospermia

Treatments: Drug: L-carnitine; Drug: Letrozole 2.5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07669402

IR.TUMS.MEDICINE.REC.1403.465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Letrozole

Experimental group

Description:

Letrozole 2.5 mg administered orally once daily for 3 months.

Treatment:

Drug: Letrozole 2.5mg

L-Carnitine Monotherapy

Experimental group

Description:

L-Carnitine 1000 mg administered orally once daily for 3 months.

Treatment:

Drug: L-carnitine

Combination Therapy

Experimental group

Description:

Letrozole 2.5 mg plus L-Carnitine 1000 mg administered orally once daily for 3 months.

Treatment:

Drug: Letrozole 2.5mg

Drug: L-carnitine