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IRCT20220809055653N1 IRCT 2022-08-19 Bandare-abbas University of Medical Sciences The effect of coenzyme Q10 on sperm in infertile men The effect of coenzyme Q10 on sperm functional parameters and mitochondria, and apoptotic process in infertile men 2022-10-07 anticipated 30 Complete https://irct.ir/trial/65204 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be performed (each block consists 6 patients). Allocation sequence and concealment codes will be generated using www.sealedenvelope.com. The closed envelope method will be used to hide the allocation sequence. 3 Male Infertility. Intervention 1: Intervention group: Oligoasthenoteratozoospermia patients receiving two tablets of sperigen daily manufactured by BioArvand Pharmed Pharmaceutical Company and two tablets of coenzyme Q10 100 mg (200 mg daily) manufactured by Golden Life Pharmaceutical Company for one month. Intervention 2: Intervention group: Oligoasthenoteratozoospermia patients receiving two tablets of sperigen daily manufactured by BioArvand Pharmed Pharmaceutical company for one month. Intervention 3: Control group: Oligoasthenoteratozoospermia patients not receive medication. Yes - There is a plan to make this available What will be shared: Information regarding the study outcomes will be shared. When: Data will become available after publication of obtained results. To whom: Only academic institutions Conditions: The study protocol or proposal should be approved by Ethics committee of institutions. The rights of authors and sponsors should be respected Where to obtain: m.omid1364@gmail.com How to obtain: Requests should be addressed to the Technology and Research Vice-chancellery of Hormozgan University of Medical Sciences and the project executor should informed. Comments:
public Mahmoud Omidi
Emam Hossein Blvd
Bandar Abbas Iran (Islamic Republic of) 7919691982 +98 76 3371 0406 m.omid1364@gmail.com Bandare-abbas University of Medical Sciences scientific Fatemeh Eini
Jomhuri Eslami Blvd
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3371 0393 feini13@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Infertile couple with a male cause identified by the symptoms of idiopathic oligoasthenoteratospermia. Definitive diagnosis of oligoasthenoteratospermia based on sperm count of less than 15 million per cc of semen, Sperm movement less than 32, Normal sperm morphology less than 4%. Men age range 18-50 years old Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm. 18 years 50 years Male Patients with a history of reproductive system problems, including: undescended testicles, Klinefelter syndrome, hypogonadism, varicocele, cryptorchidism, and azoospermia and infection in reproductive tract and reproductive system Patients with a history of inflammation and injury to the testicles that caused infertility Patients with underlying disorder including: diabetes mellitus, hypothalamus and pituitary diseases and with thyroid gland problems, hypervitaminosis D and A, kidney stones and uncontrolled hypertension History of allergy to the components of medicines: sperigen tablets and Q10 supplement N46.1 Oligospermia Treatment - Drugs Treatment - Drugs N/A Intervention group: Oligoasthenoteratozoospermia patients receiving two tablets of sperigen daily manufactured by BioArvand Pharmed Pharmaceutical Company and two tablets of coenzyme Q10 100 mg (200 mg daily) manufactured by Golden Life Pharmaceutical Company for one month Intervention group: Oligoasthenoteratozoospermia patients receiving two tablets of sperigen daily manufactured by BioArvand Pharmed Pharmaceutical company for one month. Control group: Oligoasthenoteratozoospermia patients not receive medication Sperm functional parameters (morphology, movement, number). Timepoint: Before intervention and during the study and the endpoint the study. Method of measurement: Para-clinical. Permeability of sperm mitochondrial membrane. Timepoint: Before intervention and during the study and the endpoint the study. Method of measurement: Measuring the mitochondrial membrane potential (MMP). Breakage rate of sperm nuclear DNA. Timepoint: Before intervention and during the study and the endpoint the study. Method of measurement: SDFA kit. Reactive oxygen species (ROS) level of semen liquid. Timepoint: Before intervention and during the study and the endpoint the study. Method of measurement: ROS kit. Expression level of apoptosis genes: survivin (anti-apoptotic gene) and caspase 3 (apoptotic gene). Timepoint: Before intervention and during the study and the endpoint the study. Method of measurement: RT-PCR. Bandare-abbas University of Medical Sciences Approved 2021-10-18 Ethics committee of Hormozgan University of Medical Sciences Jomhuri Eslami Blvd Bandar Abbas Hormozgan Iran (Islamic Republic of)