]>
IRCT20260502069232N1 IRCT 2026-06-25 Tehran University of Medical Sciences effect of Letrozole, L-carnitine and their combination therapy on sperm quality and male infertility Evaluation of the Efficacy of Letrozole and L-Carnitine on Sperm Quality and Oxidative Stress in infertile Men with Idiopathic Oligoasthenoteratozoospermia: A prospective, double blind, randomized clinical trial 2023-08-20 anticipated 90 Complete https://irct.ir/trial/89807 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: A block randomization method was used, in which screening was performed in the first stage and out of 120 patients, 30 patients were excluded from the study due to lack of inclusion or withdrawal criteria. The remaining 90 patients were randomly divided into three groups of 30 patients in blocks of six, and sealed envelopes were used to conceal allocation, Blinding description: The random sequence is generated by the software and the group code is given to the researcher. One group will take letrozole + L-carnitine placebo + combination placebo, one group will take L-carnitine + letrozole placebo + combination placebo and the third group will take letrozole + L-carnitine + closed design (without additional placebo). All patients take the same number of tablets/capsules daily. For the analyst; the data for each group is provided to him in the form of a, b and c. 2 Male infertility remains a major challenge in reproductive medicine, withidiopathic oligoasthenoteratozoospermia accounting for a substantial proportion of cases. Intervention 1: Intervention group one: Received letrozole tablets. Name of the substance used: Letrozole - Chemical composition and concentration: 2.5 mg tablet containing the active ingredient letrozole (C₁₇H₁₁N₅) - Manufacturer: Soha Pharma Co., Iran - Dosage: 2.5 mg (one whole tablet) once a day - Duration of treatment: 3 consecutive months (90 days) - Method of administration: Orally and after dinner (in order to reduce possible gastrointestinal side effects and increase patient adherence to treatment). Additional notes on interventions:1. Adherence to treatment: In order to increase patient adherence to the treatment regimen, patients are asked to complete a daily medication record sheet and at the end of each month, the number of pills is counted. 2. Complication management: A regular monthly follow-up program is planned by an andrology specialist to assess possible complications (such as decreased libido, fatigue, mood swings, and arthralgia) and to perform periodic hormonal tests. 3. Equipment and measurement methods: All assessments will be performed using standard and up-to-date equipment and in strict compliance with WHO guidelines (2021 version). Intervention 2: Second intervention group (L-carnitine treatment):- Name of the active ingredient: L-carnitine - Chemical composition and concentration: 1000 mg capsule containing the active ingredient L-carnitine - Manufacturer: Karen Pharma Co., Iran - Dosage: 1000 mg (one whole capsule) once a day - Duration of treatment: 3 consecutive months (90 days) - Method of administration: Orally after dinner. Additional notes on interventions:1. Adherence to treatment: In order to increase patient adherence to the treatment regimen, patients are asked to complete a daily medication record sheet and at the end of each month, the number of pills is counted. 2. Complication management: A regular monthly follow-up program is planned by an andrology specialist to assess possible complications (such as decreased libido, fatigue, mood swings, and arthralgia) and to perform periodic hormonal tests. 3. Equipment and measurement methods: All assessments will be performed using standard and up-to-date equipment and in strict compliance with WHO guidelines (2021 version). Intervention 3: Third intervention group (combination therapy) - Name of the substance used: Letrozole + L-carnitine - Chemical composition and concentration: 2.5 mg Letrozole tablet + 1000 mg L-carnitine capsule - Manufacturer: Soha Pharma Co. and Karen Pharma Co., Iran - Dosage: 2.5 mg Letrozole + 1000 mg L-carnitine (one tablet + one capsule) once a day - Duration of treatment: 3 consecutive months (90 days) - Method of administration: Orally, after dinner. Additional notes on interventions:1. Adherence to treatment: In order to increase patient adherence to the treatment regimen, patients are asked to complete a daily medication record sheet and at the end of each month, the number of pills is counted. 2. Complication management: A regular monthly follow-up program is planned by an andrology specialist to assess possible complications (such as decreased libido, fatigue, mood swings, and arthralgia) and to perform periodic hormonal tests. 3. Equipment and measurement methods: All assessments will be performed using standard and up-to-date equipment and in strict compliance with WHO guidelines (2021 version). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Azim Hedayatpour
Poursina Street; Faculty of Medicine; Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3412 hedayatpour@sina.tums.ac.ir Tehran University of Medical Sciences scientific Azim Hedayatpour
Poursina Street; Faculty of Medicine; Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3412 hedayatpour@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) body mass index (BMI) between 18 and 25 a history of normalfertility and medical background normal findings in physical examinations sperm DNAfragmentation index (DFI) greater than 15% regular sexual activity with normal sexualfunction 25 years 45 years Male genital infections azoospermia, cryptorchidism, andvaricocele history of trauma or surgery on the testes endocrine disorders systemic diseases,and use of medications affecting fertility smoking, alcohol consumption recent antioxidanttherapy any indication of female partner infertility Z31.41 Encounter for fertility testing Rehabilitation Rehabilitation Rehabilitation Intervention group one: Received letrozole tablets. Name of the substance used: Letrozole - Chemical composition and concentration: 2.5 mg tablet containing the active ingredient letrozole (C₁₇H₁₁N₅) - Manufacturer: Soha Pharma Co., Iran - Dosage: 2.5 mg (one whole tablet) once a day - Duration of treatment: 3 consecutive months (90 days) - Method of administration: Orally and after dinner (in order to reduce possible gastrointestinal side effects and increase patient adherence to treatment). Additional notes on interventions:1. Adherence to treatment: In order to increase patient adherence to the treatment regimen, patients are asked to complete a daily medication record sheet and at the end of each month, the number of pills is counted. 2. Complication management: A regular monthly follow-up program is planned by an andrology specialist to assess possible complications (such as decreased libido, fatigue, mood swings, and arthralgia) and to perform periodic hormonal tests. 3. Equipment and measurement methods: All assessments will be performed using standard and up-to-date equipment and in strict compliance with WHO guidelines (2021 version). Second intervention group (L-carnitine treatment):- Name of the active ingredient: L-carnitine - Chemical composition and concentration: 1000 mg capsule containing the active ingredient L-carnitine - Manufacturer: Karen Pharma Co., Iran - Dosage: 1000 mg (one whole capsule) once a day - Duration of treatment: 3 consecutive months (90 days) - Method of administration: Orally after dinner. Additional notes on interventions:1. Adherence to treatment: In order to increase patient adherence to the treatment regimen, patients are asked to complete a daily medication record sheet and at the end of each month, the number of pills is counted. 2. Complication management: A regular monthly follow-up program is planned by an andrology specialist to assess possible complications (such as decreased libido, fatigue, mood swings, and arthralgia) and to perform periodic hormonal tests. 3. Equipment and measurement methods: All assessments will be performed using standard and up-to-date equipment and in strict compliance with WHO guidelines (2021 version). Third intervention group (combination therapy) - Name of the substance used: Letrozole + L-carnitine - Chemical composition and concentration: 2.5 mg Letrozole tablet + 1000 mg L-carnitine capsule - Manufacturer: Soha Pharma Co. and Karen Pharma Co., Iran - Dosage: 2.5 mg Letrozole + 1000 mg L-carnitine (one tablet + one capsule) once a day - Duration of treatment: 3 consecutive months (90 days) - Method of administration: Orally, after dinner. Additional notes on interventions:1. Adherence to treatment: In order to increase patient adherence to the treatment regimen, patients are asked to complete a daily medication record sheet and at the end of each month, the number of pills is counted. 2. Complication management: A regular monthly follow-up program is planned by an andrology specialist to assess possible complications (such as decreased libido, fatigue, mood swings, and arthralgia) and to perform periodic hormonal tests. 3. Equipment and measurement methods: All assessments will be performed using standard and up-to-date equipment and in strict compliance with WHO guidelines (2021 version). Progressive motility of sperm. Timepoint: Before performing the ART technique. Method of measurement: using a phase contrast microscope (Olympus LX71, Japan) at a magnification of400×. Sperm concentration. Timepoint: Before performing the ART technique. Method of measurement: using a phase contrast microscope (Olympus LX71, Japan) at a magnification of400×. Sperm morphology. Timepoint: Before performing the ART technique. Method of measurement: using a phase contrast microscope (Olympus LX71, Japan) at a magnification of400×. Tehran University of Medical Sciences Approved 2024-12-21 Research Ethics Committee, Faculty of Medicine, Tehran University of Medical Sciences Qods street, Enghelab Square, Tehran Town Tehran Tehran Iran (Islamic Republic of)